The Establishment of Emerging Trial Regions

C L I N I C A L T R I A L M AGNIFIER
Feb 2011 Volume 4, Issue 1
The Establishment of Emerging Regions

Some obvious globalization trends can be observed between regions and countries. One particular trend is the increased focus on North Asia (+1.2% sites) and East Europe (+0.4%), taking the attention from established regions (1.1%) and Latin America (-0.4%). Another trend is that relatively small countries in established regions such as the Nordic Countries are still losing positions. The decade-long globalization trend, i.e. the shift of industry-sponsored clinical trials to emerging regions is still ongoing now with an increased industry synchronized focus on North Asia. Notably, China has for the first time entered the mainstream of this globalization process, and Japan is no longer isolated to only conducting locally registered clinical trials. Welcome Japan and welcome China!
Contents of this Issue

Pages
2-3 7-23
Article/Editorial/Commentaries
Editorial. The Establishment of Emerging Trial Regions.
25-32 34-35 36-42
Magnifier Advisory Board Members.

The Taiwanese Story. New Trial Registration.
Clinical Trial Conferences

4 Society for Clinical Trials 32nd Annual Meeting, May 15-18, 2011, Vancouver, Canada. 5
Clinical Trial Magnifier 2011 Conference,

November 2011, Taipei, Taiwan.
33
OOTR 7th Annual Conference, May 1314, 2011, Hong Kong SAR, China.
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Apr 2011, Volume 4, Issue 2
It has been said that arguing against globalization is like arguing against the laws of gravity. Kofi Annan (1938-)
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Page 2
Clinical Trial Magnifier Vol. 4:1 Feb 2011
Something about nothing

In the air -17,696km
During a recent meeting in Stockholm, Sweden a participant had difficulty in keeping his eyes open and suggested to take a break for a few hours in the afternoon. He had arrived from New York the day before and suffered from jetlag and poor sleep. Sixhour time difference and a mere 8-hour flight only such flights are like peanuts nowadays. Currently, the longest commercial, scheduled non-stop flights are between: (1) New York and Singapore, a 19hour flight of 15,345 km with a time difference of 12 hours; (2) Johannesburg and Atlanta, a 17-hour flight of 13,582 km with a time difference of 7 hours; (3) Dubai and Los Angeles, a 16-hour flight of 12,951 km with a time difference of 12 hours; and New York and Hong Kong, a 16-hour flight of 12,951 km with a time difference of 12 hours. Those flights are absolutely horrifying - it is in effect similar to twisting the brain 180 degrees. A few weeks ago, I travelled by air from Stockholm, Sweden to Dunedin on the southern part of the South Island, New Zealand a flight from winter to summer and from darkness to lightness. There is no direct flight between those two cities so I had a good reason to stop over in Hong Kong for a few days. Anyhow, the distance between Stockholm and Dunedin is 17,696km to be exact, with a time difference of 12 hours. It should have taken 21 hours to complete this flight non-stop. Hong Kong is virtually located half-way on the route from Stockholm and Dunedin. Stockholm registered temperatures of -11 C, Hong Kong +11C and Dunedin +21C.
Dinner conversation
During a social dinner in Dunedin, we discussed our travel experiences and visits to other countries. One gentleman told us that he wished to live half the year in the northern hemisphere and the other half in the southern hemisphere, if only he could afford it. So the question was raised, Johan, if you must choose, where
would like to live? In Stockholm, in Hong Kong or in Dunedin? I told them that I could easily live in any of
the three cities, although they are completely different. Stockholm the capital of Sweden - is a small large city with a sizable port, beautiful historical and proud buildings, clean water and clean air. Hong Kong is a financial metropolitan with one of the largest bycapacity ports worldwide, with virtually no historical buildings left, no clean water and no clean air. Dunedin is a large small city with a port, clean water and clean air. Dunedin not only houses the oldest university of the three cities, the university is the oldest in the entire southern hemisphere. In addition, Dunedin also has the oldest golf club the southern hemisphere.
Time flies
During the two connecting flights, I made two reflections. First, when we were young we played in the sandbox building castles, mountains and valleys, we joked that soon we will reach a tower of a building in
Stockholm 59 North and -11 C

It was the end of the Ice Age that brought the first inhabitants to Scandinavia more than twelve thousand years ago. The earliest written mention of the name Stockholm dates back to 1252; the first part of the name stock means log in Swedish, and the second part of the name holm means islet. Stockholm was built much because of the waterways. Being located in a strategic spot, as it were, trade was an important factor, and, therefore, it became vital to fortify the islands of the inner city with a wall. The University of Stockholm was first established in 1878 and is today 133 years old.
China. More correctly, it should have been a tower in Dunedin. Second, I understand why the birds are
leaving the Scandinavian countries for the southern hemisphere during the long, cold and dark winter. In fact, this is what the Scandinavians are doing today at least for a few weeks during the winter season. Maybe it is not a coincidence that the first transatlantic flight was made by Charles Augustus Lindbergh, the only child of a Swedish Native. His non-stop journey from Long Island to Paris took 33 hours and was completed in the evening of May 21, 1927. That is, this historical event took place only some 84 years ago. And it was only 61 years ago since the first non-stop transatlantic jet flight was made in 10 hours in 1950.
Clinical Trial Magnifier

Publisher: Karlberg, Johan Petter Einar ISSN 2078-8185 Copyright 2011. All Rights Reserved by the Publisher.
Page 3
Something about a new thing

This Magnifier issue addresses the globalization of industry-sponsored clinical trials a topic that has been addressed several times previously. The present analyses are based on phase II/III trials registered in the US trial registry and is focused on the changes noted between two periods, namely 2006.01/2008.06 and 2008.07/2010.12. A significant shift in the number of study sites can be noted from the established trial regions and Latin America to Asia and partially to East Europe. In Asia,
Hong Kong 22 North and +11 C

Archaeological findings suggesting human activity in Hong Kong dates back over 30,000 years. The name "Hong Kong" is an approximate phonetic rendering of the pronunciation of the spoken Cantonese name meaning "fragrant harbour" in English. Hong Kong was just a collection of fishing villages when claimed by Britain in 1842 following the First Opium War with China. Starting out as a fishing village, salt production site and trading ground, it would evolve into a military port of strategic importance and eventually an international financial centre. The University of Hong Kong was founded in 1911 and is thus celebrating the anniversary of its first century this year.
we can note that South Korea, China and Taiwan have recently become more popular among the life sciences industry, while India - still popular - is losing ground to the countries in the north. Maybe the most notable observation is that Japan has entered the main stream of multi-national industry-sponsored clinical trials; five years ago, about 90% of all Japanese trial sites were involved in local registration trials, while today about 50% are involved in multi-national industrysponsored clinical trials. Japan is no longer in
isolation.
Emerging early phase trials

Another observation made from the analyses of the US trial registry data is that the proportion of phase II trials conducted in emerging clinical trial regions has increased significantly. This trend is important and should be noted. However, there is still a lack or almost vacuum of commercial accredited phase I trial units with good track records in emerging regions. One exception is a phase I unit owned by Dr. CheungTak Hung in Dunedin, New Zealand. The company Zenith Technology was founded in 1987 and serves clients not only from North America and Europe, but also the Asia-Pacific region.
Copy and paste

During the week of travel to Stockholm and Dunedin, I had the thought of wanting to copy and paste two initiatives, if possible, back to Hong Kong to develop the region into an emerging bio-tech hub: (a) The Karolinska Development, Stockholm - the leading translational research initiative of an academic institution; and (b) The Zenith Technology phase I unit in Dunedin, one of the few commercial Asian-Pacific phase I units operating to international standards. Johan Karlberg, MD, PhD, BSc Editor, Clinical Trial Magnifier Hong Kong, February 2011
Dunedin 46 South and +21 C

New Zealand's first inhabitants are believed to be the Maori, although it had also been hypothesized that the first Polynesians to inhabit what is now New Zealand arrived around 800 AD. The name Dunedin itself was derived from the Gaelic word for Edinburgh, the capital of Scotland. Dunedin was founded by the Presbyterian Free Church of Scotland in 1848. In 1861, the discovery of gold at Gabriel's Gully led to a rapid influx of immigrants. Dunedin is home to the University of Otago, New Zealand's first university founded in 1869, or 142 years ago.
Page 4
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2011 Conference November
Taipei - Taiwan
Conference Focus
Clinical Research Infrastructure Development
Conference Chair
Johan Karlberg, MD, PhD Visiting Professor Taipei Medical University
Conference Secretariat
aoncheng@hku.hk
Page 6
Portuguese
Portuguese is spoken by 240 million persons worldwide in total
Free download (pdf file) at www.ClinicalTrialMagnifier.com
Page 7
The Establishment of Emerging Trial Regions

By Johan PE Karlberg, MD, PhD, BSc Clinical Trials Centre, The University of Hong Kong, Hong Kong SAR, PR China
Abstract
The objective of the current study is to depict the globalization of industry-sponsored clinical trials based on the US trial registry five-year set of data, i.e. from January 1, 2006 to December 31, 2010. The analysis will also be made for two consecutive 2.5-year periods with the purpose of observing any changes in the distribution of the number of phase II/III industrysponsored clinical trial sites over continents and countries. Phase III trials had on average around 47 sites per trial and phase II trials about 18 sites per trial; together, phase II and III trials represent 58.3% and 86.0% of all industry-sponsored trials and sites registered, respectively. Over the five years there were 7,603 phase II/III trials registered and initiated with 242,931 study sites. Based on all five years of observation, North America and Europe (Western) contributed 45.6% and 24.6% of all phase II/III study sites, respectively, giving a total of 70.2% for the established regions. However, North America and Europe have jointly lost 1.1% (chi-square test, p<0.05) of the number of study sites over the two 2.5-year period of observation; the percentage has changed from 70.7% (95% confidence interval: 70.43-70.93%) to 69.6% (95% confidence interval: 69.35 to 69.87%). The number of sites have increased in both Asia and East Europe during the two periods of observation by 1.2% (chi-square test, p<0.05) and 0.4% (chi-square test, p<0.05), respectively while the number has decreased in Latin America and Africa by 0.4% (chi-square test, p<0.05). For the period of 2008.07 to 2010.12, East Europe was still the most popular emerging region for industry-sponsored clinical trials with 12.5% of the total number of sites, while Asia now contributes 9.7% of all sites globally. The emerging clinical trial countries can no longer be called emerging countries, owing to the fact the globalization of industrysponsored clinical trials have been taking place since the introduction of the ICH GCP Guideline in 1997. However, a few recent, obvious trends can still be observed between regions and countries, notably an increased focus on North Asia and East Europe, taking the attention from established regions and Latin America. Another trend is that relatively small countries in established regions are still losing positions. In a new moment in time of translational medicine, industry collaboration is a must for translating discoveries into useful medical treatments and procedures and also in fostering the next generation of biomedical scientists. This causative relationship has now been widely accepted both by government bodies and academia, and this will drive the competition between countries to an even higher level.
Summary
The objective of this study is to depict the globalization of industry-sponsored clinical trials based on phase II/III clinical trials registered in the US trial registry between 2006 and 2010. Some obvious globalization trends can be observed between regions and countries, notably an increased focus on North Asia (+1.2% sites) and East Europe (+0.4%), taking the attention from established regions (-1.1%) and Latin America (-0.4%). Another trend is that relatively small countries in established regions such as the Nordic Countries are still losing positions. The decade-long globalization trend, i.e. the shift in industry-sponsored clinical trials to emerging regions is still ongoing now with an increased industry synchronized focus on North Asia. Notably, China has for the first time entered the mainstream of this globalization process, and Japan is no longer isolated to only conducting locally registered trials. Welcome Japan and welcome China!
Page 8
English
English is spoken by 900 million persons worldwide in total
Free download (pdf file) at www.ClinicalTrialMagnifier.com Printed version for purchase at www.CTMagnifier.com
Page 9
Introduction
There are many important factors to the globalization of industry-sponsored clinical trials, namely knowledge transfer, education, access to promising new treatments, international collaborations, and financial incentives. It is thus crucial to continuously follow this process to be able to answer questions like: How far will this process go? Have we reached a
Extracted Information: Register identifier, date of first

registration, date of study onset, date of last update, study phase (phase I-IV), type of study (observational or experimental), primary sponsor, therapeutic/disease area, study site location (i.e. country and city, with institution occasionally listed), global sample size, study status, and type of intervention being investigated.
plateau of globalization, or is the process still ongoing and uninterrupted?

In 2008, the globalization trends of industrysponsored clinical trials were described in detail in the
Analysis Dataset: The following inclusion/exclusion

criteria restricted the analysis: (I) Interventional studies of drugs and biologics were included and not observational studies or clinical trials of devices, procedures or preventions; (II) Only phase I-IV defined trials; (III) Trials first registered between January 1, 2006 and December 31, 2010 were included, giving three years of data; (IV) Trials initiated on January 1, 2006 or later were included; (V) Only trials under the planning, recruiting, ongoing or completed stage were included (and not terminated or halted trials).
Clinical Trial Magnifier (CTM).1 The data series was

drawn from the US trial registry, representing two years of data, including new industry-sponsored trials registered from October 2005 to September 2007. Countries outside North America and Europe contributed one-out-of-five clinical trial study sites. The results strongly indicated that the international pharmaceutical, biotech and medical device industries were rapidly rethinking their strategy by locating more clinical trial study sites to emerging countries with large populations and large market potential, with a particular focus on the four BRIC countries. In 2009, CTM repeated the analysis and the geographic distribution of the number of industry-sponsored phase II/III clinical trial study sites registered in the US trial registry between January 2006 and December 2008 - 3 full years - was reported in CTM.2 North America now contributed 48.4% of the sites, while Europe and rest-of-world contributed 24.6% and 27.0% respectively. The distribution for the rest-of-world can be broken down into: East Europe (11.0%), Asia (7.6%), Latin America (4.6%), Oceania (1.8%), Africa (1.0%) and the Middle East (0.8%). The objective of the current study is to repeat the analysis based on a five-year set of data, i.e. from January 1, 2006 to December 31, 2010. The analysis will also be made for two consecutive 2.5-year periods with the purpose of observing any changes in the distribution of the number of phase II/III industrysponsored clinical trial sites over continents and countries.
Phase I Trials: The Food and Drug Administration

Amendments Act of 2007 came into law on September 27, 2007, and was later enacted on September 30, 2007.4 The 2007 FDA Amendments Act expands the requirement to register virtually all clinical trials involving drugs, biologics and devices. The registry databank must include all applicable drug clinical trials as a condition of a New Drug Application approval. Applicable drug clinical trials include all controlled clinical investigations of a product other than phase I clinical investigations. For each drug under clinical testing, there is on average some 22 phase I trials (unpublished observation based on the GlaxoSmithKline clinical trial data register), and the proportion of phase I trials in the US trial registry is far below expectations. For those reasons, phase I trials have been omitted from some of the analysis.
Phase IV Trials: Industry-sponsored phase IV trials are

frequently not conducted under a regulatory approval process. Thus, the regulatory authority does not demand phase IV trials to be included in a public trials registry. Some pharmaceutical companies register several phase IV trials in the US trial registry, while other companies register few or none (unpublished observation). This inconsistency in the registration of phase IV trials, and therefore lack of representation, is the reason phase IV trials are excluded from parts of the analysis.
Methods
All clinical trials registered in www.ClinicalTrials.gov were downloaded on December 31, 2010. Essential information was extracted and coded by a tailor-made SAS program (Statistical Analysis System) developed by the author.3 The dataset was subsequently analyzed using SAS.
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Spanish
Spanish is spoken by 500 million persons worldwide in total
Page 11
Results
Phase I-IV trials - over five years
Table 1 provides information about the number of clinical trials and the associated number of study sites for all industry-sponsored phase I-IV clinical trials registered in the US trial registry that were initiated between January 2006 and December 2010, that is trials initiated over five full years. This information has been segregated into two 2.5-year periods: 2006.01 to 2008.06 and 2008.07 to 2010.12. The results are also depicted graphically in Figures 1-2. Differences in the numbers for the two periods can be observed. For example, there was an increase in the number of phase I trials over time from 1,584 to 2,461. Phase II and phase III trials represent 25.0% and 61.0% of all sites, respectively with similar figures for the two periods under observation (Table 1, Figure 2). The analysis will be based on Phase II and III trials since they are legally enforced to be registered in the US trials registry if those trials are under the US FDA oversight. Phase III trials have on average around 47 sites per trial and phase II trials about 18 sites per trial (Figure 2); together, phase II and III trials represent 58.3% and 86.0% of all industry-sponsored trials and sites registered, respectively (Table 1).
number of related study sites for 2006.01 to 2008.06 (Table 3), for 2008.07 to 2010.12 (Table 4) and for 2006.01 to 2010.12 (Table 5) for the leading 60 countries ranked by the total number of sites over the five years of observation. Tables 3-4 include information for both phase II and III trials and give the geographic distribution of the trials; a local trial is defined as a trial that is conducted in one country, and a multi-national trial is defined as a trial conducted in more than one country. Table 5 provides information about the change in the number of study sites over the two 2.5-year periods for each country. The countries with the largest absolute percentage change in the number of study sites between the two 2.5 years of observation are graphically displayed in Figure 5. Tables 3-4 highlight a few recent trends over the two 2.5-year periods of observation; (1) Japans proportion of the number of local industry sponsored trial sites has decreased a fall from 78.9% to 53.3%; (2) several emerging countries such as Russia and Poland have increased their proportion of the number of phase II trial sites based on the total number of phase II/III trial sites from about 23% to 32%; but (3) China, on the other hand, still holds a relatively low proportion of the number of phase II trial sites 8.1% and 10.1%. Table 5 and Figure 5 give details about the change in the percentage of the number of industry-sponsored II/III trial sites over the two 2.5-year periods of observation. Eleven countries had a significant (p<0.05) increase in the percentage, with South Korea and China representing the top two gainers. They are accompanied by another three Asian countries, namely Taiwan, Japan and Thailand. There were fifteen countries that experienced a significant decrease in the percentage of sites (Figure 5), with Argentina and Canada positioned in the lower tale of the distribution.
Phase II/III trials by continent

Table 2 and Figures 3-4 show the distribution of the number of phase II/III trials and the number of related study sites over time and continent. Based on all five years of observation, North America and Europe (Western) contributed 45.6% and 24.6% of all phase II/III study sites, respectively, giving a total of 70.2% for the established regions. North America and Europe have jointly lost 1.1% (chi-square test, p<0.05) of the number of study sites over the two 2.5-year period of observation (Figure 2, Figure 4); the percentage has changed from 70.7% (95% confidence interval: 70.4370.93%) to 69.6% (95% confidence interval: 69.35 to 69.87%). The number of sites has increased in both Asia and East Europe during the two periods of observation by 1.2% (chi-square test, p<0.05) and 0.4% (chi-square test, p<0.05), respectively while the number has decreased in Latin America and Africa by 0.4% (chi-square test, p<0.05). For the period of 2008.07 to 2010.12, East Europe was still the most popular emerging region for industry-sponsored clinical trials with 12.5% of the total number of sites, while Asia now contributes 9.7% of all sites globally.
Country ranking and site density

Table 6 and Figure 6 give the ranking of the leading 60 countries according to the number of industrysponsored trial sites over five years (2006-2010). Information about the site density is also provided, i.e. the annual number of sites per million population. Emerging countries such as the Czech Republic and Hungary have site density figures of over 60 sites per million population - comparable to that of the US. However, most emerging countries have large growth potential, especially Asian countries (Figure 7); all eleven Asian countries listed in Table 5 have a site population density of below 16 sites per million, while all 21 established countries in North America and Europe have reached site density values of 16 or more. A majority of the East European countries 10 out of 16 also have site density figures of 16 or above.
Phase II/III trials by country

Tables 3-5 and Figure 5 include the number of industry-sponsored phase II/III clinical trials and the
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Chinese (Mandarin)
Mandarin is spoken by 1,200 million persons worldwide in total
JUST RELEASED
Page 13
Table 1. The number of clinical trials and corresponding number of study sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 and between July 2008 and December 2010, respectively.
2006.01 to 2008.06 Trials Phase I II III IV n 1,584 1,888 1,867 712 Sites n 5,891 33,714 90,779 15,913
2008.07 to 2010.12 Trials n 2,461 2,071 1,777 678
. Sites n 7,466 Trials n 4,045 3,959 3,644 1,390
Total
. Sites n 13,357 70,528 172,403 26,326 Trials % 31.0 30.4 27.9 10.7
Total Sites % 4.7 25.0 61.0 9.3
36,814 81,624 10,413
Total
II+III
6,051
3,755
146,297
124,493
6,987
3,848
136,317
118,438
13,038
7,603
282,614
242,931
100.0
58.3
100.0
86.0
Year of study initiation and trial phase

2006.01 to 2008.06 Phase I Phase II Phase III Phase IV
1,584 1,888 1,867 712 15,913 5,891 33,714
Source: Clinical Trial Magnifier Vol. 4:1 Feb 2011 www.ClinicalTrialMagnifier.com
90,779
2008.07 to 2010.12 Phase I Phase II Phase III Phase IV 3,000 2,000

2,461 2,071 1,777 678 10,413 7,466 36,814 81,624
Figure 1. The number of clinical trials and corresponding number of study sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 and between July 2008 and December 2010, respectively. Values taken from Table 1.
1,000
50,000
100,000
Trials (n)
Sites (n)
Year of study initiation and trial phase

2006.01 to 2008.06 Phase I Phase II Phase III Phase IV
48.6 22.3 10.9 17.9 3.7 4.0 23.0
62.1
2008.07 to 2010.12 Phase I Phase II Phase III Phase IV 75.0 50.0

45.9 15.4 7.6 17.8 3.0 5.5 27.0 59.9
Figure 2. The number of sites per trial and percentage of all sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 and between July 2008 and December 2010, respectively by trial phase. Values derived from Table 1.
75.0
25.0
0.0
25.0
50.0
Sites per trial (n)
Percentage of all sites (%)
Page 14
Table 2. The number of phase II/III trials and number of related study sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 or between July 2008 and December 2010, respectively by continent. Note that a certain trial can be conducted in more than one continent and is thus counted more than once.
Change in the number of sites Period 1 2006.01 to 2008.06 Trials Continent N America Europe (Western) n 2,260 1,544 Sites n 57,044 30,943 . Sites % 45.8 24.9 Trials n 2,372 1,581 Period 2 2008.07 to 2010.12 Sites n 53,658 28,783 . Sites % 45.3 24.3 Trials n 4,632 3,125 Sites n 110,702 59,734 Total Sites % 45.6 24.6 Sites / trial n 23.9 19.1 . over the two period Percentage Change % Chi-square -0.5 (NS) -0.6 (p<0.05) Relative Change % -1.1 -2.2 .
Total
East Europe Asia Latin America Oceania Middle East Africa
3,804
879 884 563 418 215 310
87,987
15,148 10,586 5,857 2,411 1,062 1,442
70.7
12.2 8.5 4.7 1.9 0.9 1.2
3,953
934 996 579 409 252 232
82,441
14,860 11,466 5,103 2,330 1,058 1,180
69.6
12.5 9.7 4.3 2.0 0.9 1.0
7,757
1,813 1,880 1,142 827 467 542
170,436
30,008 22,052 10,960 4,741 2,120 2,622
70.2
12.4 9.1 4.5 2.0 0.9 1.1
22.0
16.6 11.7 9.6 5.7 4.5 4.8
-1.1 (p<0.05)
0.4 (p<0.05) 1.2 (p<0.05) -0.4 (p<0.05) 0.0 (NS) 0.0 (NS) -0.2 (NS)
-1.5
3.1 13.9 -8.4 1.6 4.7 -14.0
Total Grand Total

for Period 1.
3,269 7,073
36,506 124,493
29.3 100.0
3,402 7,355
35,997 118,438
30.4 100.0
6,671 14,428
72,503 242,939
29.8 100.0
10.9 16.8
1.1 (p<0.05) 0.0
3.6 0.0
(*) The changed number of sites over the two periods is based on the percentage change in the number of sites between the two periods multiplied with the actual total number of sites
Year of study initiation and the number of phase II/III trial sites
2006.01 to 2008.06 North America Europe East Europe Asia Latin America Oceania Middle East Africa 2008.07 to 2010.12 North America Europe East Europe Asia Latin America Oceania Middle East Africa 75,000 50,000
57,044 30,943 24.9 45.8
15,148 10,586 5,857 2,411 1,062 1,442
12.2 8.5 4.7 1.9 0.9 1.2
Figure 3. The number of phase II/III study sites for all industry-sponsored trials registered in the US trial registry with the study initiation date between January 2006 to June 2008 and between July 2008 and December 2010, respectively by continent. Values taken from Table 2.
53,658 28,783 24.3
45.3
14,860 11,466 5,103 2,330 1,058 1,180 4.3 2.0 0.9 1.0
12.5 9.7
25,000
0.0 0
10.0 20.0 30.0 40.0 50.0 60.0
Sites (n)
Percentage of all sites (%)
1.5
Change (%) site number

1.2
1.0
Change (%) in site number
Change between 2006.01/2008.06 and 2008.07/2010.12

Figure 4. Change in the percentage of
0.0 0.0
0.5
0.4
industry-sponsored phase II/III trial sites registered in the US trial registry

-0.2
0.0
for studies with initiation dates between January 2006 to June 2008 and between July 2008 and December 2010, respectively. The results are
-0.5
-0.4 -0.5 -0.6
-1.0
th or
Am
er
ic
a E
o ur
pe E st Ea
o ur
pe
As
ia in at Am
er
ic
a O
an ce
ia
r Af
ic
a M id dl e
st Ea
given by continent. Values taken from Table 2.
Continent
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Table 3. The number of phase II/III trials and the number of related study sites for all industry-sponsored trials registered in the US trial registry with a study initiation date between January 2006 and June 2008 (2.5 years). The leading 60 countries ranked by the total number of sites over five years of observation (2006 to 2010) are included. Local sites are defined as trials only conducted in one country.
2006.01 to 2008.06 Multi-national trials Phase II Trials Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Country US Germany France Canada Japan Spain Italy Russia UK Poland India Australia Belgium Czech Rep. Hungary Brazil Argentina China Netherlands Ukraine South Korea Mexico Romania South Africa Israel Sweden Austria Taiwan Slovakia Bulgaria Denmark Finland Turkey Greece Switzerland Chile Norway Portugal Philippines Peru Colombia Thailand New Zealand Lithuania Malaysia Latvia Estonia Serbia Croatia Hong Kong Ireland Singapore Guatemala Belarus Georgia Indonesia Tunisia Egypt Costa Rica Lebanon n 426 274 199 242 11 193 171 133 211 149 79 123 132 97 86 49 68 12 95 50 55 68 71 71 51 85 74 44 44 53 63 46 31 30 48 42 48 26 22 29 14 26 28 31 14 23 27 22 21 15 16 24 5 2 6 3 5 7 4 5 . n 8,056 1,534 898 1,193 97 726 649 696 693 669 537 475 392 431 424 189 255 52 266 314 175 223 305 314 208 216 170 141 163 225 179 116 90 76 76 113 117 62 59 69 44 52 74 87 33 51 58 55 56 32 25 34 9 2 25 3 5 12 7 6 Phase III Trials n 547 447 355 404 45 344 330 267 323 338 211 255 269 254 225 194 225 96 229 152 173 202 158 180 138 195 198 130 137 100 146 135 106 112 132 117 91 96 77 81 69 68 79 81 63 71 83 65 60 83 61 67 15 21 5 16 15 14 16 8 Sites . . n 22,050 5,048 3,197 3,344 743 2,520 2,340 2,307 2,254 2,267 1,609 1,573 1,272 1,304 1,178 1,433 1,434 854 1,087 1,056 769 951 697 922 778 746 708 488 512 471 525 474 338 401 406 321 338 345 295 255 203 204 221 255 179 179 184 172 166 158 172 112 18 54 7 60 41 29 25 12 Phase II Trials n 667 68 27 35 92 19 27 8 41 2 12 13 16 0 2 4 3 7 9 0 12 5 1 4 9 11 13 9 0 1 10 8 3 1 7 3 2 0 4 0 1 4 3 0 1 1 1 2 0 1 2 1 1 0 1 0 0 2 0 1 Sites Local trials . n 8,597 333 192 173 987 243 87 53 117 7 59 32 19 0 8 14 11 45 13 0 30 22 14 6 25 47 13 32 0 1 14 26 6 6 8 11 5 0 4 0 1 10 5 0 10 2 3 4 0 3 2 1 5 0 4 0 0 3 0 1 Phase III Trials n 484 65 26 18 129 15 16 6 16 7 14 10 3 3 1 27 4 50 6 0 26 4 0 4 3 1 3 5 0 0 9 5 6 0 5 0 2 0 5 2 0 3 0 0 2 0 1 0 0 2 0 1 0 0 0 1 0 0 1 0 Sites . . n 13,465 811 343 166 2,151 158 148 58 111 48 58 31 4 21 10 107 18 245 95 0 93 9 0 22 3 19 31 16 0 0 9 45 53 0 5 0 5 0 17 14 0 5 0 0 21 0 1 0 0 3 0 4 0 0 0 1 0 0 1 0 Phase II Trials n 1,093 342 226 277 103 212 198 141 252 151 91 136 148 97 88 53 71 19 104 50 67 73 72 75 60 96 87 53 44 54 73 54 34 31 55 45 50 26 26 29 15 30 31 31 15 24 28 24 21 16 18 25 6 2 7 3 5 9 4 6 . n 16,653 1,867 1,090 1,366 1,084 969 736 749 810 676 596 507 411 431 432 203 266 97 279 314 205 245 319 320 233 263 183 173 163 226 193 142 96 82 84 124 122 62 63 69 45 62 79 87 43 53 61 59 56 35 27 35 14 2 29 3 5 15 7 7 Sites Sites Multi-national + local trials Phase III Trials n 1,031 512 381 422 174 359 346 273 339 345 225 265 272 257 226 221 229 146 235 152 199 206 158 184 141 196 201 135 137 100 155 140 112 112 137 117 93 96 82 83 69 71 79 81 65 71 84 65 60 85 61 68 15 21 5 17 15 14 17 8 . Sites n 35,515 5,859 3,540 3,510 2,894 2,678 2,488 2,365 2,365 2,315 1,667 1,604 1,276 1,325 1,188 1,540 1,452 1,099 1,182 1,056 862 960 697 944 781 765 739 504 512 471 534 519 391 401 411 321 343 345 312 269 203 209 221 255 200 179 185 172 166 161 172 116 18 54 7 61 41 29 26 12 Trials n 2,124 854 607 699 277 571 544 414 591 496 316 401 420 354 314 274 300 165 339 202 266 279 230 259 201 292 288 188 181 154 228 194 146 143 192 162 143 122 108 112 84 101 110 112 80 95 112 89 81 101 79 93 21 23 12 20 20 23 21 14 Total . . Sites n 52,168 7,726 4,630 4,876 3,978 3,647 3,224 3,114 3,175 2,991 2,263 2,111 1,687 1,756 1,620 1,743 1,718 1,196 1,461 1,370 1,067 1,205 1,016 1,264 1,014 1,028 922 677 675 697 727 661 487 483 495 445 465 407 375 338 248 271 300 342 243 232 246 231 222 196 199 151 32 56 36 64 46 44 33 19 Phase II Sites % 31.9 24.2 23.5 28.0 27.2 26.6 22.8 24.1 25.5 22.6 26.3 24.0 24.4 24.5 26.7 11.6 15.5 8.1 19.1 22.9 19.2 20.3 31.4 25.3 23.0 25.6 19.8 25.6 24.1 32.4 26.5 21.5 19.7 17.0 17.0 27.9 26.2 15.2 16.8 20.4 18.1 22.9 26.3 25.4 17.7 22.8 24.8 25.5 25.2 17.9 13.6 23.2 43.8 3.6 80.6 4.7 10.9 34.1 21.2 36.8 Local Sites % 42.3 14.8 11.6 7.0 78.9 11.0 7.3 3.6 7.2 1.8 5.2 3.0 1.4 1.2 1.1 6.9 1.7 24.2 7.4 0.0 11.5 2.6 1.4 2.2 2.8 6.4 4.8 7.1 0.0 0.1 3.2 10.7 12.1 1.2 2.6 2.5 2.2 0.0 5.6 4.1 0.4 5.5 1.7 0.0 12.8 0.9 1.6 1.7 0.0 3.1 1.0 3.3 15.6 0.0 11.1 1.6 0.0 6.8 3.0 5.3
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Table 4. Number of phase II/III trials and the number of related study sites for all industry-sponsored trials registered in the US trial registry with a study initiation date between July 2008 and December 2010 (2.5 years). The leading 60 countries ranked by the total number of sites over the five years of observation (2006 to 2010) are included. Local sites are defined as trials only conducted in one country.
2008.07 to 2010.12 Multi-national trials Phase II Trials Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Country US Germany France Canada Japan Spain Italy Russia UK Poland India Australia Belgium Czech Rep. Hungary Brazil Argentina China Netherlands Ukraine South Korea Mexico Romania South Africa Israel Sweden Austria Taiwan Slovakia Bulgaria Denmark Finland Turkey Greece Switzerland Chile Norway Portugal Philippines Peru Colombia Thailand New Zealand Lithuania Malaysia Latvia Estonia Serbia Croatia Hong Kong Ireland Singapore Guatemala Belarus Georgia Indonesia Tunisia Egypt Costa Rica Lebanon n 507 344 232 272 53 200 192 133 207 194 66 130 177 115 108 50 61 15 119 62 89 51 95 47 55 90 70 67 51 53 67 51 31 25 44 25 38 22 18 25 27 27 31 23 13 27 25 27 20 35 21 34 8 1 10 2 1 5 2 6 . n 8,243 2,188 1,185 1,217 400 929 835 940 786 998 436 572 531 491 527 209 237 51 269 368 339 197 419 265 207 228 169 194 227 212 153 135 110 73 95 74 104 74 41 74 82 54 70 55 33 86 63 72 61 54 38 46 16 1 42 4 2 8 3 22 Phase III Trials n 582 455 354 398 102 328 305 282 321 313 180 249 250 199 178 149 160 81 205 122 183 206 180 145 143 170 146 146 113 89 144 101 111 110 98 84 71 84 85 83 95 100 70 62 68 61 63 51 49 70 49 55 33 22 8 10 12 14 18 13 Sites . . n 22,850 4,502 3,004 2,758 1,444 2,216 2,093 2,068 1,925 1,859 1,451 1,390 1,065 995 976 919 833 930 971 907 920 1,051 853 724 665 670 488 583 470 432 433 330 469 374 287 298 223 300 338 286 327 310 247 192 234 188 175 155 156 138 114 84 83 68 41 41 53 27 41 36 Phase II Trials n 760 84 24 40 76 9 25 9 38 4 11 10 10 4 4 5 1 9 4 0 16 9 2 5 30 11 5 10 1 0 4 6 3 0 6 2 4 1 3 1 0 2 2 0 0 0 0 0 0 2 0 1 0 0 2 2 0 0 1 0 Sites Local trials . n 8,453 372 188 138 793 84 183 52 110 23 38 38 69 22 8 23 1 108 15 0 70 16 9 23 74 22 9 45 2 0 5 55 10 0 8 2 7 6 3 1 0 2 3 0 0 0 0 0 0 7 0 5 0 0 6 5 0 0 2 0 Phase III Trials n 391 47 21 16 118 6 15 1 11 2 17 3 9 3 2 78 0 62 5 0 35 5 3 1 4 1 5 11 0 0 2 7 6 0 4 0 1 0 4 0 1 1 0 0 1 0 0 0 0 1 0 2 0 0 0 0 1 1 1 1 Sites . . n 9,926 297 251 73 1,314 13 135 1 45 2 125 10 22 11 2 202 0 484 19 0 161 16 3 1 12 7 5 41 0 0 3 38 44 0 5 0 1 0 11 0 16 3 0 0 4 0 0 0 0 1 0 4 0 0 0 0 6 4 1 1 Phase II Trials n 1,267 428 256 312 129 209 217 142 245 198 77 140 187 119 112 55 62 24 123 62 105 60 97 52 85 101 75 77 52 53 71 57 34 25 50 27 42 23 21 26 27 29 33 23 13 27 25 27 20 37 21 35 8 1 12 4 1 5 3 6 . n 16,696 2,560 1,373 1,355 1,193 1,013 1,018 992 896 1,021 474 610 600 513 535 232 238 159 284 368 409 213 428 288 281 250 178 239 229 212 158 190 120 73 103 76 111 80 44 75 82 56 73 55 33 86 63 72 61 61 38 51 16 1 48 9 2 8 5 22 Sites Sites Multi-national + local trials Phase III Trials n 973 502 375 414 220 334 320 283 332 315 197 252 259 202 180 227 160 143 210 122 218 211 183 146 147 171 151 157 113 89 146 108 117 110 102 84 72 84 89 83 96 101 70 62 69 61 63 51 49 71 49 57 33 22 8 10 13 15 19 14 . Sites n 32,776 4,799 3,255 2,831 2,758 2,229 2,228 2,069 1,970 1,861 1,576 1,400 1,087 1,006 978 1,121 833 1,414 990 907 1,081 1,067 856 725 677 677 493 624 470 432 436 368 513 374 292 298 224 300 349 286 343 313 247 192 238 188 175 155 156 139 114 88 83 68 41 41 59 31 42 37 Total Trials n 2,240 930 631 726 349 543 537 425 577 513 274 392 446 321 292 282 222 167 333 184 323 271 280 198 232 272 226 234 165 142 217 165 151 135 152 111 114 107 110 109 123 130 103 85 82 88 88 78 69 108 70 92 41 23 20 14 14 20 22 20 . . Sites n 49,472 7,359 4,628 4,186 3,951 3,242 3,246 3,061 2,866 2,882 2,050 2,010 1,687 1,519 1,513 1,353 1,071 1,573 1,274 1,275 1,490 1,280 1,284 1,013 958 927 671 863 699 644 594 558 633 447 395 374 335 380 393 361 425 369 320 247 271 274 238 227 217 200 152 139 99 69 89 50 61 39 47 59 Phase II Sites % 33.7 34.8 29.7 32.4 30.2 31.2 31.4 32.4 31.3 35.4 23.1 30.3 35.6 33.8 35.4 17.1 22.2 10.1 22.3 28.9 27.4 16.6 33.3 28.4 29.3 27.0 26.5 27.7 32.8 32.9 26.6 34.1 19.0 16.3 26.1 20.3 33.1 21.1 11.2 20.8 19.3 15.2 22.8 22.3 12.2 31.4 26.5 31.7 28.1 30.5 25.0 36.7 16.2 1.4 53.9 18.0 3.3 20.5 10.6 37.3 Local Sites % 37.2 9.1 9.5 5.0 53.3 3.0 9.8 1.7 5.4 0.9 8.0 2.4 5.4 2.2 0.7 16.6 0.1 37.6 2.7 0.0 15.5 2.5 0.9 2.4 9.0 3.1 2.1 10.0 0.3 0.0 1.3 16.7 8.5 0.0 3.3 0.5 2.4 1.6 3.6 0.3 3.8 1.4 0.9 0.0 1.5 0.0 0.0 0.0 0.0 4.0 0.0 6.5 0.0 0.0 6.7 10.0 9.8 10.3 6.4 1.7
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Table 5. Number of phase II/III trials and number of related study sites for all industry-sponsored trials registered in the US trial registry, initiated between January 2006 and December 2010 (5.0 years). The leading 60 countries ranked according to the total number of sites over the five years of observation (2006 to 2010) are included.
2006.01 to 2010.12 Multi-national trials Phase II Trials Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Country US Germany France Canada Japan Spain Italy Russia UK Poland India Australia Belgium Czech Republic Hungary Brazil Argentina China Netherlands Ukraine South Korea Mexico Romania South Africa Israel Sweden Austria Taiwan Slovakia Bulgaria Denmark Finland Turkey Greece Switzerland Chile Norway Portugal Philippines Peru Colombia Thailand New Zealand Lithuania Malaysia Latvia Estonia Serbia Croatia Hong Kong Ireland Singapore Guatemala Belarus Georgia Indonesia Tunisia Egypt Costa Rica Lebanon n 2,360 770 482 589 232 421 415 283 497 349 168 276 335 216 200 108 133 43 227 112 172 133 169 127 145 197 162 130 96 107 144 111 68 56 105 72 92 49 47 55 42 59 64 54 28 51 53 51 41 53 39 60 14 3 19 7 6 14 7 12
. .
Proportion of all sites Phase II

.
Phase III Sites Per trial n 34.1 10.5 9.0 7.6 14.3 7.1 7.1 8.0 6.5 6.3 7.7 5.8 4.5 5.1 5.3 5.9 5.9 8.7 4.9 7.2 4.7 4.9 4.6 5.1 5.1 3.9 3.5 3.9 3.9 4.8 3.2 3.6 3.9 3.5 2.9 3.1 3.4 3.6 3.9 3.3 3.3 3.0 3.1 3.1 3.3 2.8 2.4 2.8 3.0 1.9 2.6 1.6 2.1 2.8 3.7 3.8 3.6 2.1 1.9 2.2 % 41.8 6.2 3.8 3.7 3.3 2.8 2.7 2.5 2.5 2.4 1.8 1.7 1.4 1.3 1.3 1.3 1.1 1.1 1.1 1.1 1.1 1.0 0.9 0.9 0.8 0.8 0.7 0.6 0.6 0.6 0.5 0.5 0.5 0.4 0.4 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.1 0.1 0.1 0.1 0.0 0.0 0.0 0.0 0.0
2006 to 2008 % 41.9 6.2 3.7 3.9 3.2 2.9 2.6 2.5 2.6 2.4 1.8 1.7 1.4 1.4 1.3 1.4 1.4 1.0 1.2 1.1 0.9 1.0 0.8 1.0 0.8 0.8 0.7 0.5 0.5 0.6 0.6 0.5 0.4 0.4 0.4 0.4 0.4 0.3 0.3 0.3 0.2 0.2 0.2 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0
2008 to 2010 % 41.8 6.2 3.9 3.5 3.3 2.7 2.7 2.6 2.4 2.4 1.7 1.7 1.4 1.3 1.3 1.1 0.9 1.3 1.1 1.1 1.3 1.1 1.1 0.9 0.8 0.8 0.6 0.7 0.6 0.5 0.5 0.5 0.5 0.4 0.3 0.3 0.3 0.3 0.3 0.3 0.4 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.1 0.1 0.1 0.1 0.0 0.1 0.0 0.0 0.0 Change % -0.13 0.01 0.19 -0.38 0.14 -0.19 0.15 0.08 -0.13 0.03 -0.09 0.00 0.07 -0.13 -0.02 -0.26 -0.48 0.37 -0.10 -0.02 0.40 0.11 0.27 -0.16 -0.01 -0.04 -0.17 0.18 0.05 -0.02 -0.08 -0.06 0.14 -0.01 -0.06 -0.04 -0.09 -0.01 0.03 0.03 0.16 0.09 0.03 -0.07 0.03 0.04 0.00 0.01 0.00 0.01 -0.03 0.00 0.06 0.01 0.05 -0.01 0.01 0.00 0.01 0.03
Phase III Trials n 2,004 1,014 756 836 394 693 666 556 671 660 422 517 531 459 406 448 389 289 445 274 417 417 341 330 288 367 352 292 250 189 301 248 229 222 239 201 165 180 171 166 165 172 149 143 134 132 147 116 109 156 110 125 48 43 13 27 28 29 36 22
Total Trials n 4,364 1,784 1,238 1,425 626 1,114 1,081 839 1,168 1,009 590 793 866 675 606 556 522 332 672 386 589 550 510 457 433 564 514 422 346 296 445 359 297 278 344 273 257 229 218 221 207 231 213 197 162 183 200 167 150 209 149 185 62 46 32 34 34 43 43 34
Sites Per trial n 14.1 5.7 5.1 4.6 9.8 4.7 4.2 6.2 3.4 4.9 6.4 4.0 3.0 4.4 4.8 4.0 3.8 6.0 2.5 6.1 3.6 3.4 4.4 4.8 3.5 2.6 2.2 3.2 4.1 4.1 2.4 3.0 3.2 2.8 1.8 2.8 2.5 2.9 2.3 2.6 3.0 2.0 2.4 2.6 2.7 2.7 2.3 2.6 2.9 1.8 1.7 1.4 2.1 1.0 4.1 1.7 1.2 1.6 1.7 2.4
Sites n 33,349 4,427 2,463 2,721 2,277 1,982 1,754 1,741 1,706 1,697 1,070 1,117 1,011 944 967 435 504 256 563 682 614 458 747 608 514 513 361 412 392 438 351 332 216 155 187 200 233 142 107 144 127 118 152 142 76 139 124 131 117 96 65 86 30 3 77 12 7 23 12 29
Sites n 68,291 10,658 6,795 6,341 5,652 4,907 4,716 4,434 4,335 4,176 3,243 3,004 2,363 2,331 2,166 2,661 2,285 2,513 2,172 1,963 1,943 2,027 1,553 1,669 1,458 1,442 1,232 1,128 982 903 970 887 904 775 703 619 567 645 661 555 546 522 468 447 438 367 360 327 322 300 286 204 101 122 48 102 100 60 68 49
Sites n 101,640 15,085 9,258 9,062 7,929 6,889 6,470 6,175 6,041 5,873 4,313 4,121 3,374 3,275 3,133 3,096 2,789 2,769 2,735 2,645 2,557 2,485 2,300 2,277 1,972 1,955 1,593 1,540 1,374 1,341 1,321 1,219 1,120 930 890 819 800 787 768 699 673 640 620 589 514 506 484 458 439 396 351 290 131 125 125 114 107 83 80 78
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Discussion
The drift is still on!
As reported in CTM during 2008 and 2009, there was a clear drift of industry-sponsored clinical trial sites from established to emerging regions.1-2 This drift is still ongoing (2008.07 to 2010.12); the current percentages for the drift of phase II/III trials is 1.1% from North America and Europe to Asia (+1.2%) and to East Europe (+0.4%). A new drifting pattern has been identified; Latin America has recently lost 0.4% of the global number of study sites. Over the past few years, concerns have been raised by both the US and Europe about the impact of the globalization of industry-sponsored clinical trials.5-7 The concerns are, in principle, of two kinds: (i) the quality of the data collected in emerging regions and (ii) the representativeness of the test results for the target population of the medicinal products tested, i.e. in the US and in Europe, respectively. However, those concerns have seemingly not affected this ongoing globalization process. In the industry, it is still believed that it is a good option to move more and more trials into emerging locations to accelerate the completion of the clinical development test programs in compliance with local and international regulations and guidelines.
both Japan and China were not part of this development, since most of their trials were for local registration purposes only. This observation has apparently changed, and it appears that both Japan and China have now entered the mainstream of multicentre clinical trials testing new medicinal products on a global level. It can be assumed that this development will continue, because both Japan and China are of great interest to the international life sciences industry. By including both countries in the new medicinal products testing program, thus avoiding locally registered trials pharmaceutical sales in the two countries can be initiated much faster than at present. The impact of the economic growth of China must also be noted and accepted: China has just overtaken Japan as the worlds second largest economy and is predicted to overtake US leading position in 2020.
North Asia is serious

Amongst the top eight global countries that have recently gained the most ground in the number of industry-sponsored trial sites are South Korea (#1), China (#2), Taiwan (#5) and Japan (#8). Clearly, North Asia is in the focus of the global life sciences R&D Boards. Asias share of industry-sponsored sites has recently increased by 1.2%, attributed virtually by North Asian countries, while there does not appear to be an increased contribution amongst the South Asian countries, with the exception of Thailand. For instance, the previous trend of increase in the number of trial sites observed for India has now halted or rather stabilized.
Welcome Japan and welcome China!

In a previous CTM article, it was reported that in 2005/2007 Asia contributed 5.9% of all industrysponsored study sites - a number that has now increased to 9.7%.8 It was also noted at the time that
Industry-sponsored phase II/III clinical trial sites

South Korea China Romania France Taiwan Colombia Italy Japan Turkey Mexico Thailand
0.27 0.19 0.18 0.16 0.15 0.14 0.14 0.11 0.09

0.40 0.37
Switzerland Lithuania Denmark India Norway Netherlands US UK Czech Republic South Africa Austria Spain Brazil Canada Argentina -0.60
-0.06 -0.07 -0.08 -0.09 -0.09 -0.10 -0.13 -0.13 -0.13 -0.16 -0.17 -0.19 -0.26 -0.38 -0.48
-0.40
-0.20
0.00
0.20
0.40
0.60
Figure 5. The change in the percentage of industrysponsored phase II/III trial sites registered in the US trial registry with a study initiation date between January 2006 to June 2008 and between July 2008 and December 2010, respectively. The results are presented for countries with the largest absolute and significant (p<0.05) change. Values taken from Table 5.
Change (%) from 2006.01/2008.06 to 2008.07/2010.12
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Table 6. The number of phase II/III study sites for all industry-sponsored trials registered in the US trial registry, initiated between January 2006 and December 2010 (5.0 years) by country and population size. Countries in red have shown the highest decrease in the relative number of sites from 2006.01-2008.06 and 2008.07-2010.12, while countries in green have shown the largest increase (Table 5). The site density is also given as the annual number of industry-sponsored trial sites per million population.
2006.01-2008.06 Sites Country US Germany Canada France Japan Spain Italy UK Russia Poland India Australia Czech Rep. Brazil Argentina Belgium Hungary Netherlands Ukraine South Africa Mexico China South Korea Sweden Romania Israel Austria Denmark Bulgaria Taiwan Slovakia Finland Switzerland Turkey Greece Norway Chile Portugal Philippines Lithuania Peru New Zealand Thailand Colombia Estonia Malaysia Latvia Serbia Croatia Ireland Hong Kong Singapore Indonesia Belarus Tunisia Egypt Georgia Costa Rica Guatemala Lebanon n 52,168 7,726 4,876 4,630 3,978 3,647 3,224 3,175 3,114 2,991 2,263 2,111 1,756 1,743 1,718 1,687 1,620 1,461 1,370 1,264 1,205 1,196 1,067 1,028 1,016 1,014 922 727 697 677 675 661 495 487 483 465 445 407 375 342 338 300 271 248 246 243 232 231 222 199 196 151 64 56 46 44 36 33 32 19
2008.07-2010.12 Sites n 49,472 7,359 4,186 4,628 3,951 3,242 3,246 2,866 3,061 2,882 2,050 2,010 1,519 1,353 1,071 1,687 1,513 1,274 1,275 1,013 1,280 1,573 1,490 927 1,284 958 671 594 644 863 699 558 395 633 447 335 374 380 393 247 361 320 369 425 238 271 274 227 217 152 200 139 50 69 61 39 89 47 99 59
2006.01-2010.12 Sites / year n 20,328 3,017 1,812 1,852 1,586 1,378 1,294 1,208 1,235 1,175 863 824 655 619 558 675 627 547 529 455 497 554 511 391 460 394 319 264 268 308 275 244 178 224 186 160 164 157 154 118 140 124 128 135 97 103 101 92 88 70 79 58 23 25 21 17 25 16 26 16
Population Million n 311.9 81.8 34.3 65.8 127.4 46.2 60.5 61.8 141.9 38.1 1,193.1 22.5 10.5 190.7 40.1 10.8 10.0 16.6 45.8 50.0 112.3 1,341.9 48.5 9.4 21.5 7.7 8.4 5.6 7.5 23.2 5.4 5.4 7.8 72.6 11.3 4.9 17.2 10.6 94.0 3.2 29.5 4.4 67.1 45.8 1.3 28.3 2.2 9.9 4.6 4.5 7.1 5.1 237.6 9.5 10.4 79.7 4.4 4.6 14.4 4.3
Sites per year and million population n 65.2 36.9 52.8 28.1 12.4 29.9 21.4 19.6 8.7 30.8 0.7 36.6 62.3 3.2 13.9 62.3 62.6 32.9 11.6 9.1 4.4 0.4 10.5 41.5 21.4 51.3 37.9 47.5 35.6 13.3 50.6 45.3 22.9 3.1 16.5 32.4 9.5 14.8 1.6 36.3 4.7 28.2 1.9 2.9 72.2 3.6 45.4 9.3 19.2 15.7 11.2 11.4 0.1 2.6 2.0 0.2 5.6 3.5 1.8 3.7
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Based on the number of industry-sponsored trial sites, the rankings of China, South Korea and Taiwan have improved over the past five years, from 22nd to 14th, 23rd 17th and 30th to 27th, respectively. However, Japan, ranked 5th, and India, ranked 11th, have managed to retain their respective positions. The significance of North Asia is further implied by the fact that 28 of Asias 32 universities listed in the top 200 world universities of Times Higher Education, World University Rankings 2010 are located to North Asia: Japan (n=10), China (n=6), Hong Kong (n=5),
South Korea (n=5) and Taiwan (n=2).9 Over the past 10 years China, including Hong Kong, has significantly increased its academic output in the biomedical research area and has today more Medlinelisted articles than the UK and Japan, second only to the US.10 North Asia contributed about 16% of all Medline publications in 2009, equivalent to approximately half of the figures for North America and Europe (Westerns), respectively: China (6.7%), Japan (5.8%), South Korea (2.1%), Taiwan (1.0%) and Hong Kong (0.4%). South Asia, Oceania, Africa, Middle
Country
US Germany Canada France Japan Spain Italy UK Russia Poland India Australia Czech Rep. Brazil Argentina Belgium Hungary Netherlands Ukraine South Africa Mexico China South Korea Sweden Romania Israel Austria Denmark Bulgaria Taiwan Slovakia Finland Switzerland Turkey Greece Norway Chile Portugal Philippines Lithuania
65.2 52.8 36.9 28.1 29.9 21.4 19.6 12.4 1 2 3 4
30.8 62.3 62.3 62.6 36.6 13.9 32.9
8.7 0.7 3.2
11.6 9.1 10.5 21.4
4.4 0.4
41.5 51.3 47.5 50.6 45.3 37.9 35.6
13.3 22.9
32.4
16.5 14.8 9.5
3.1
36.3
1.6
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
Figure 6. The ranking of the leading 40 countries according to the number of sites over a five-year observation, from 2006-2010. Information about the site density is also provided, i.e. the annual number of such sites per million population. Values taken from
50
80
70
60
50
40
30
20
10
10
20
30
40
Table 6.
Sites/million population
Ranking 2010.12

12
Number of countries
11 9 Asia N America/Europe East Europe 6 6 5 6
10
Figure 7. The annual number of industry-sponsored phase II/III trial sites per million population for 11 countries in Asia, 16 countries in East Europe and 21 countries in North America or Europe, respectively based on the US trial registry data for 2006 to 2010. Values taken from Table 6.
4
3 2
0 0 to 15 16 to 30 31 to 45 46 or above
Site density - study sites per million population
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East, East Europe and Latin America each contributed between 2.3% and 4.0% of all Medline publications in 2009. If one was to see new biotech hubs developed in the world, one would likely assume that a few would appear in North Asia. The objective of a bio-medical cluster is to transfer novel discoveries usually made at academic institutions - by commercialization - into clinical practice. The concept of translational medicine also recently became a strong trend in the US and Europe. For instance, the US National Institutes of Health priority areas of 2009 listed translational medicine second after genomics. During the past few years, there has been new developments in the US with the selection of a national consortium of institutions funded by the NIH translational research aimed at accelerating the transition from scientific discoveries to medical therapies. There are three distinct prerequisites for the development of a successful bio-medical cluster: (a) excellent basic and clinical sciences to breed novel discoveries, (b) venture capital expertise to identify novel discoveries suitable for commercialization, and (c) a strong infrastructure, unique network and a relevant supporting organizational structure to facilitate the discovery-commercialization process. Outside Japan, a rapid breed of the three crucial prerequisites can also be noted in some of the major North Asian cities such as Beijing, Shanghai, Seoul, Hong Kong and Taipei. Those cities and maybe other cities in North Asia are in the position to capture on this opportunity.
Argentina, Canada and Brazil in stagnation

Argentina, Canada and Brazil have recently lost study sites to other countries. Argentina is presently contributing 0.9% of all industry-sponsored phase II/III trial sites compared to 1.4% a few years ago. This represents a relative decrease with over 35% corresponding to a loss of about 600 study sites. Argentina dropped from 15th to 23rd in the rankings due to a fall in the number of industry-sponsored phase II/III trial sites, while Brazil slipped from 14th to 18th and Canada from 3rd to 4th. In the case of Canada, the recent decline in the number of industry-sponsored clinical trial sites may be understandable. Canada has a high site density, with over 50 sites per million population. The selection of site location is commonly made at the sponsors head office in the US or Europe. With the ongoing decline in the number of sites located to established regions, it can be assumed that it is more strategic to locate a site to the US rather than to Canada. Both Argentina and Brazil - with large populations and relatively low site density figures - have recently shown a significant decline in the number of industrysponsored trial sites. It is very difficult to understand the reasons for such an imperative strategic alteration in locating clinical trials to Argentina and Brazil. It may be related to regulatory, contractual or GCP compliance issues, for instance. We are calling for commentaries on this observation from the readers of CTM. To be noted, Mexico - also included among the Latin American countries has not shown a similar trend, but rather an increase in the number of study sites.
Figure 8. The shift in industrysponsored phase II/III trial sites from 2006.01 to 2008.06 and 2008.07 to 2010.12. The green points represent a gain in the number of sites, while the red points a loss in the number of sites. Values taken from Table 5.
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Diverged pattern in Europe

There are five countries in Europe that have been able to keep or improve their ranking based on the number of trial sites during the past five years, namely Germany (no change) , France (up 1) , Italy (up 1), Belgium (up 3) and Greece (up 1). However, the remaining nine most active European countries have lost their original places in the ranking. Notably, the UK has slipped two positions from 8th place to 10th bypassed by both Russia and Poland. The four large Nordic countries have together lost 13 ranking positions, or over three places on average. The general trend for Europe is that the number of study sites has risen in large countries, while the number has fallen in small populated countries. The reason for this is most certainly because the sponsor selects countries where the most study sites can be identified for each individual study protocol. The potential market size may also influence the selection of study site location, but for the UK this does not seem to be the case.
annual revenue of the Korean investigative sites can thus have increased by US$ 47 million, possibly reaching US$ 152 million. There is significant additional revenue associated with industry-sponsored trials globally and annually, corresponding to US$ 23 billion. Some of this revenue will be diverted to the head quarters of the trial sponsor and/or clinical trial services provider, but a significant portion will be invested in the country where the trial is conducted. The international life sciences industry may thus spend another US$ 100 million annually in South Korea on top of the US$ 152 million in study site stipends.
Trial and site volume trends

There has been an increase in the number of trials (15.5%) registered in the US trial registry over the two 2.5-year periods 2006.01 to 2008.06 and 2008.07 to 2010.12, respectively. However, this increase is mostly attributed to the number of phase I trials (+55.4%) and partially phase II trials (+9.7%), while both phase III (4.8%) and IV (-4.8%) trials have decreased in numbers. The change in phase II-IV trials may represent a fluctuation or variation normally expected over a certain period of time. The significant increase in the number of phase I trials is, however, more than expected, since phase I trials registration is not a mandatory requirement by the US FDA; an exception is when they are conducted in patients with life threatening diseases.4 For each new successful drug, it is estimated that 22 phase I trials are conducted compared to three phase II and three phase III trials (unpublished observation based on the GlaxoSmithKline clinical trial data register). The number of phase I trials should thus exceed the number of phase II trials by at least seven times without considering the fact that the majority of drugs under clinical testing will not reach the market. Based on the US trial registry, the number of phase I trials is in fact about the same as the number of phase II or phase III trials. This means many phase I trials are not registered in the US trial registry. Thus, interpretations about phase I trials should not be made. Phase II and III trials represent about 86% of all sites, while phase I and IV trials represent the remaining 14%. Overall, the number of sites has decreased by 6.8% over the two 2.5-year periods 2006.01 to 2008.06 and 2008.07 to 2010.12, respectively. The number of phase II sites has increased by 9.2%, which is in line with the increase in the number of phase II trials (9.7%). However, the number of phase III sites has decreased by 10.1% compared to a decrease of 4.8% in the number of phase III trials. This observation is consistent with our previous unpublished observation
Selection of site location

The site selection process has become an important part of the strategic decision making of the life sciences industry. Countries with large populations, good track records and efficient infrastructure are the winners. Relatively small countries must excel in one way or another to stay competitive. Any country with poor track records will not be seriously considered, even if the population is large. Countries with low standards of healthcare will also be less attractive, because they have difficulties mimicking the standards of healthcare of established regions. The globalization of industry sponsored-clinical trials is still ongoing, but it has matured into a more stable and predictable process. Most countries have realized that involvement in industry-sponsored clinical research comes with the benefits of revenue, employment, education and status. For instance, the annual global expenditure of the life sciences industry on clinical research and development is estimated to be US$ 35 billion and about one-third of this investment is directed to the investigative study sites.11 More simply, this can be translated to a 1.1% volume decrease - as reported here for North America and Europe - representing an annual revenue loss of US$ 140 million in study site grants. During the past decade, South Korea has been able to establish an outstanding and attractive infrastructure for industry-sponsored trials. The result of this investment reported to be in the range of US$ 100 million - is that the site contribution made by South Korea has increased from 0.9% to 1.3%, or by 0.4% of the global number of sites within a few years. The total
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that additional study sites are continuously added into the US trial registry, especially for ongoing phase III trials. Therefore, at no point in time were all the sites identifiable, especially for trials recently registered and initiated.
3. 4.
Statistical Analysis System, Version 9.1.3. SAS Institute, Cary, North Carolina, US, 2007. U.S. Food and Drug Administration. FDA Modernization Act of 2007. Available online at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=110_cong_public_la ws&docid=f:publ085.110.
Conclusions
The emerging clinical trial countries can no longer be called emerging countries, owing to the fact the globalization of industry-sponsored clinical trials have been taking place since the introduction of the ICH GCP Guideline in 1997. However, a few recent, obvious trends can still be observed between regions and countries, notably an increased focus on North Asia and East Europe, taking the attention from established regions and Latin America. Another trend is that relatively small countries in established regions are still losing positions. In a new moment in time of translational medicine, industry collaboration is a must for translating discoveries into useful medical treatments and procedures and also in fostering the next generation of biomedical scientists. This causative relationship has now been widely accepted both by government bodies and academia, and this will drive the competition between countries to an even higher level.
5.
European Medicines Agency. EMEA strategy paper: Acceptance of clinical trials conducted in third countries, for evaluation in Marketing Authorization Applications 2008. Available online at http://www.emea.europa.eu/Inspections/doc s/22806708en.pdf.
6.
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009:19;816-23.
7.
Challenges to FDAs Ability to Monitor and Inspect Foreign Clinical Trials. Department of Health and Human Services, Office of Inspector General (Report # OEI-01-0800510), 2010. Available online at http://oig.hhs.gov/oei/reports/oei-01-0800510.pdf.
8.
Karlberg JPE. Development of sponsored clinical trials in Asia. Clinical Trial Magnifier 2008;1:77-93. Available online at http://www.ClinicalTrialMagnifier.com.
Acknowledgements
This study could not have been completed without the implementation of the ICMJE policy and the existence of the www.ClinicalTrials.gov trial register. 9.
Times University Ranking 2010-2011. Available online at http://www.timeshighereducation.co.uk/worl d-university-rankings.
References
1. Karlberg JPE. Sponsored clinical trial globalization trends. Clinical Trial Magnifier 2008;1:13-9. Available online at http://www.ClinicalTrialMagnifier.com. 2. Karlberg JPE. Uninterrupted Globalization of Industry Sponsored Clinical Trials. Clinical Trial Magnifier, 2009;2:79-94. Available online at http://www.ClinicalTrialMagnifier.com.
10. Karlberg JPE. Biomedical Publication Trends by Geographic Area. Clinical Trial Magnifier, 2009;2:682-701. Available online at http://www.ClinicalTrialMagnifier.com. 11. Getz KA. Sizing Up the Clinical Research Market. Applied Clinical Trials. Mar 1, 2010. Available online at http://appliedclinicaltrialsonline.findpharma.c om/appliedclinicaltrials/CRO%2FSponsor/Sizin g-Up-the-Clinical-ResearchMarket/ArticleStandard/Article/detail/660749.
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www.ClinicalTrialMagnifier.com editorialboard@ClinicalTrialMagnifier.com
Editorial Board
Clinical Trials Centre
Li Ka Shing Faculty of Medicine The University of Hong Kong Queen Mary Hospital 102 Pokfulam Road Hong Kong Phone: (852) 2255 4664 Fax: (852) 2974 1248 E-mail : ctcentre@hkucc.hku.hk Home page: http://www.hku.hk/ctc/
The Clinical Trial Magnifier is a free monthly electronic journal without any financial support from for-profit organizations. The University of Hong Kong, the Clinical Trials Centre, is at present the sole funding source. There are no plans to introduce a subscription fee or to obtain funding from for-profit organizations. Unconditional donations may be accepted in the future as editorial and administrative support. The Magnifier is intended for educational, research, and reference purposes only. The content of this publication should not be substituted for the advice of a qualified healthcare professional. Materials published in the Clinical Trial Magnifier (Magnifier) are the result of research and/or contribution by independent individuals or organizations. The Magnifier / The University of Hong Kong are not responsible for the accuracy or reliability of any data or conclusions reported in such materials. The Magnifier is provided "as is" without warranty of any kind. In no event will The University of Hong Kong and its employees, officers, members, agents, or licensors be liable for any damage of any kind whether direct, indirect, special, incidental, consequential or otherwise resulting from the use of or inability to use the Magnifier.
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Clinical Trial Magnifier - Advisory Board Members

Dr. Saber Mohamed ABD-ALLAH, PhD Theriogenology, Faculty of Veterinary Medicine Beni-Suef University Beni-Suef Egypt Mr. Habeeb Ibrahim ABDUL RAZACK, MSc, BPharm Clinical Pharmacology Unit GVK Biosciences Pvt Ltd. Hyderabad India Dr. Burkay ADALIG, MD Medical Division Boehringer Ingelheim Turkey Istanbul Turkey Professor Hamdi AKAN, MD Department of Hematology Ankara University Medical School Ankara Turkey Dr. Ali S.M. AL-SHANQEETI, MD Prince Sultan Hematology and Oncology Center King Fahad Medical City Riyadh Saudi Arabia Mr. Majed Ahmed ALSHAER, BSc, MSc Department of Biological Sciences King Abdul-Aziz University Jeddah Saudi Arabia Dr. Kamal Adel AMIN, PhD Biochemistry Beni Suef University Beni Suef Egypt Dr. Noureddin Nakhostin ANSARI, PhD, PT Faculty of Rehabilitation Tehran University of Medical Sciences Tehran Iran Dr. Nitin B. BAGUL, MBBS, MRCS Clinical Research MAC Neuroscience UK Manchester United Kingdom Ms. Joel M BARRA, BSBM American Institute of Research Whittier USA Professor Cristobal BELDA-INIESTA, MD, PhD Translational Oncology and Experimental Therapeutics Unit CSIC/UAM University Hospital La Paz Madrid
Spain
Dr. Maxim V. BELOTSERKOVSKY, MD, DS Medical Affairs PSI CRO AG St. Petersburg Russia Dr. As'ad E. BHORAT, MBBCH, FCFP(CMSA), DA(CMSA) Soweto Clinical Trials Centre Johannesburg South Africa Dr. Qasim E. BHORAT, MBBCH, PGD Family Med, MSM Soweto Clinical Trials Centre Johannesburg South Africa Dr. Giuseppe BIONDI ZOCCAI, MD Division of Cardiology University of Turin Turin Italy Dr. Jorge G. BORETTO, MD Hand and Upper Extremity Surgery Hospital Italiano de Buenos Aires Ciudad Autnoma de Buenos Aires Argentina Dr. Ney Carter do Carmo BORGES, MD, PhD, FACC, FACP, FAHA, FESC Internal Medicine Synchrophar Clinical Trials - FCM UNICAMP Campinas Brazil Mr. Don BUFORD iiBIG New York USA
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Clinical Trial Magnifier - Advisory Board Members (cont.)

Dr. Lesley J. BURGESS, PhD, MMed, MB BCh, PgD IRE TREAD Clinical Trial Research Unit Tygerberg Hospital Parow South Africa Professor Jose R. CARVALHEIRO, MD, PhD Ctr. for Technological Development in Health Oswaldo Cruz Foundation (Fiocruz) Rio de Janeiro Brazil Dr. Sandra K. CESARIO, RNC, BSN, MS, PhD, FAAN College of Nursing Texas Woman's University Houston USA Dr. Geetika CHAKRAVARTY, PhD Pharmacology TUHSC, SOM, Tulane University New Orleans USA Mr. Peng CHAN, BSc (Hons) Research2Trials Clinical Solutions Pte Ltd. Singapore Dr. Cheng-Shyong CHANG, MD Department of Internal Medicine Changhua Christian Hospital Changhua Taiwan Dr. Mark CHANG, PhD Biostatistics and Data Management AMAG Pharmaceuticals, Inc. Lexington USA Dr. Rajeev K. CHAVDA, MBBS, MD, DBM Clinical Research Pierre Fabre Laboratories Mumbai India Dr. Min-Hui CHEN, MD, MSG Division of Clinical Sciences Center for Drug Evaluation Taipei Taiwan Dr. Yiping CHEN, MBBS, DPhil Clinical Trial Service & Epidemiological Studies Unit Nuffield Department of Clinical Medicine University of Oxford Oxford UK Dr. Yuet-Meng CHEONG, MBBS, MMedSc, MRC/FRCPath Jeffrey Cheah School of Medicine & Health Sciences Monash University Sunway Campus Kuala Lumpur Malaysia Ms. Penny CHIPMAN, CCRP, CCRC Department of Oncology McGill University Montreal Canada Dr. Jongtae CHOI, MD, PhD, MBA Clinical Development & Medical Affairs Novartis Korea Seoul South Korea Dr. Saqib A. CHOUDHARY, PhD, MSc Technical Operations Quantum Research Solutions Liverpool United Kingdom Professor Louis CHOW, MBBS, FRCS, FCS, FHKAM, MS, FACS Breast Centre St. Teresa's Hospital Hong Kong PR China Professor Kent-Man CHU, MB, BS, MS, FRCS(Ed), FACS, FCSHK, FHKAM Department of Surgery The University of Hong Kong Hong Kong PR China Dr. Norbert CLEMENS, MD, PhD Clinical Development CRS Mannheim GmbH Gruenstadt Germany
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Dr. Jeffrey CUMMINGS, MD Mary S. Easton Center for Alzheimers Disease Research University of California Los Angeles USA Dr. Bjorn L. DAHLOF, MD, PhD Department of Emergency and Clinical Medicine University of Gothenburg Gothenburg Sweden Mr. Heber A. DAVID, MPharm Clinical Research Department Aravind Eye Care System Madurai India Dr. Linda R. DAVRATH, PhD, MSc Clinical Research Biological Signal Processing Tel Aviv Israel Dr. Peter L. DELPUTTE, PhD, MSc PROVAXS Ghent University Ghent Belgium Professor Simon T. DONELL, MD, BSc Trauma & Orthopaedics Norfolk & Norwich University Hospital/University of East Anglia Norwich UK Professor Dan L. DUMITRASCU, MD 2nd Medical Dept University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca Romania Dr. Roger O. EDWARDS, BSc, PhD Head Office Neural Diagnostics Pty Ltd. Melbourne Australia Ms. Semahat P. EISWIRTH, BSN Molecular Virology & Microbiology Baylor College of Medicine Houston USA Professor Amlcar C. FALCO, PharmD, PhD Faculty of Pharmacy University of Coimbra Coimbra Portugal Dr. James FAN, MD, MBA Medical Affairs and Drug Safety, Asia Pacific ICON Clinical Research Pte. Ltd Singapore Dr. Magora FLORELLA, MD, EM Anesthesiology & Critical Care Hadassah Medical Center Jerusalem Israel
Dr. Gerhard FORTWENGEL, PhD, MPH, MSc Faculty III Media, Information and Design Dr. Paulo Roberto G. DOS SANTOS, MSc University of Applied Sciences and Arts Clinical Advisory Unit Hannover Immunobiological Technology Institute Bio-Manguinhos Germany Rio de Janeiro Brazil Dr. Diana P.M. FREY, MD Rheumatology Department Dr. Vadim DREYZIN, MD, CCFP, FCFP University Hospital of Zurich Anapharm Inc. Zurich Toronto Switzerland Canada Dr. Fernando M. GARCIA, MD, MSc Clinical Research IMSS Mexico
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Dr. Pedro R. GARGOLOFF, MD Departamento de Investigacion Clinica Clinica Santa Teresa de Avila La Plata Argentina Dr. Claudio GRAIFF, MD Division of Medical Oncology Central Hospital ASAA-SABES Azienda Sanitaria dell'alto Adige Bolzano Italy Mrs. Melanie GENTGALL, RN, CCRC Pain and Anaesthesia Research Clinic (PARC) University of Adelaide Adelaide Australia Dr. Stefan GLCK, MD, PhD, FRCPC Division of Hematology/Oncology University of Miami Miami USA Dr. Ronald S. GO, MD Center for Cancer and Blood Disorders Gundersen Lutheran Health System La Crosse USA Professor William D. GRANT, Med EdD Emergency Medicine State University of New York Upstate Medical University Syracuse USA Ms. Lois V. GREENE, RNC, BSN, MBA Cancer Center Saint Michaels Medical Center Newark USA Dr. Michael R. HAMRELL, BS, PhD MORIAH Consultants Yorba Linda USA Dr. Markus HARTMANN, PhD, MDRA European Consulting and Contracting in Oncology Trier Germany Dr. Hiddo Lambers HEERSPINK, PharmD, PhD Department of Clinical Pharmacology University Medical Center Groningen Groningen The Netherlands Dr. Jeffrey HURST, PhD The Hershey Company Hershey USA Dr. Theresa JACOB, BS, MS, PhD, MPH Clinical Trials Unit & Translational Research Maimonides Medical Center Brooklyn USA Mr. Vikas JAIN, BE, MBA Business Development Proscizen Research Services P Ltd Ahmedabad India Mr. Babu JEYARAJ, BPharm, MBA Clinical Pharmacology Unit GVK Biosciences Pvt Ltd Hyderabad India Dr. Hans Erik JOHNSEN, MD, DMSc Department of Haematology Aalborg Hospital, Aarhus University Hospital Aalborg Denmark Dr. Zdravko A. KAMENOV, MD, PhD, DMedSc, University Clinic of Endocrinology, Alexandrovska University Hospital Medical University Bulgaria Dr. Krishna KAPHLE, BVSc, AH, PhD, GHC Theriogenology Vet Teaching Hospital, Chitwan Bharatpur Nepal
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Dr. Shiva G. KAPSI, PhD Pharmaceutical Development GlaxoSmithKline King of Prussia USA Professor Johan KARLBERG, MD, PhD, BSc Clinical Trials Centre The University of Hong Kong Hong Kong PR China Mrs. Christi L. KELLY, BS, MS Research Department Texas Neurology PA Dallas USA Professor Kyung-Soo KIM, MD, PhD Clinical Trial Center & Clinical Research Coordinating Center Catholic University of Korea Seoul Republic of Korea Dr. Andrei V. KRAVCHENKO, MD, PhD Representative Office in Ukraine Harrison Clinical Research Kiev Ukraine Dr. Giovanni LANDONI, MD Dept. of Anesthesia and Intensive Care Vita-Salute University San Raffaele Milano Italy Professor Dongho LEE, MD, PhD, MBA Department of Anesthesiology and clinical Pharmacology & Clinical Research Center Ulsan University Seoul Republic of Korea Dr. Yil-Seob LEE, MD, PhD Medical GSK Republic of Korea Seoul Republic of Korea Ms. Priscilla C.N. LI, MSc, BNursing Network Development and Secretariat Singapore Clinical Research Institute Singapore Dr. Boleslav L. LICHTERMAN, MD, PhD Russian Academy of Medical Sciences Moscow Russia Professor Paul S. LIETMAN, MD, PhD Dept. of Medicine, Pharmacology & Molecular Sciences, and Pediatrics The Johns Hopkins University School of Medicine Baltimore USA Dr. Leandro J. LINARELLO, BPharm R&D GlaxoSmithKline Argentina S.A. Buenos Aires Argentina Dr. Chia-Yih LIU, MD Department of Psychiatry Chang Gung Medical Center Kuei-San Taiwan Dr. Amparo E. MACIAS, MD, PhD Clinical Immunology Center of Molecular Immunology (CIM) C.Havana Cuba Dr. Ulf P. MALMQVIST, MD, PhD Clinical Research and Trial Centre Skne University Hospital Lund Sweden Ms. Chaya MAZOUZ, RN, MA Pluristem Therapeutics Hifa Israel Dr. Henry I. MILLER, MD The Hoover Institution Stanford University Stanford USA
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Dr. Essack MITHA, MBChB, Dip Obstetrics Newtown Clinical Research Centre Johannesburg South Africa Dr. Amirtha NAADIMUTHU, MD Clinical Operations Sanofi-aventis US Malevern USA Dr. Anil K. NAIR, MD Neurology Boston University Boston USA Dr. Shiva Murthy NANJUNDAPPA, MBBS, MD Clinical Research and Business Development Quartesian Clinical Research Pvt Ltd Bangalore India Mrs. Esther NKRUMAH, MS, CCRP Clinical Research Group Drexel University College of Medicine Philadelphia USA Ms Brenda NOLF, BSCN, MSc Medical Schering-Plough Canada Inc. Milton Canada Dr. Yelena NOVIK, MD Cancer Institute New York University School of Medicine New York USA Dr. Cem OZESEN, MD Global Clinical Trial Operations Merck Research Laboratories Istanbul Turkey Mr. Ashwani PANDITA, BPharm, MSQM Clinical Quality Assurance Reliance Life Sciences Pvt. Limited Navi Mumbai India Mr. Cyrus S. PARK, BS Microbiology, MS ChemistryClinical Pharmacology Unit Kendle International BV Utrecht The Netherlands Dr. George PERRY, PhD Biology University of Texas at San Antonio San Antonio USA Dr. Carlo PETRINI, PhD Bioethics Unit, Office of the President National Institute of Health Rome Italy
Mr. Anandprabu NARASHIMMAN, PGDCR, BPharm Clinical Trials Research Intelligence PPTS India Pvt Ltd Coimbatore India
Dr. Lars NELLEMAN, MD International Clinical Research, Asia Pacific H. Lundbeck A/S Singapore Dr. Bernard NG, MD Medical Abbott Laboratories Singapore Mr. Chong Jin NG, LLB Healthcare / Medical Diagnostics GE Healthcare Pte Ltd Singapore Ms. Jennifer L. NIEUWOUDT, BSc Medicine Boehringer Ingelheim South Africa Johannesburg South Africa
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Dr. Torben PLESNER, MD, Doc.Med. Sci Institute of Regional Health Science & Department of Hematology, Section of Internal Medicine University of Southern Denmark and Vejle Hospital Vejle Denmark Dr. Vijay R. PRABHAKAR, MD Boehringer Ingelheim Singapore Pte Ltd. Singapore Dr. Amjad RAJA, MBBS, MS (Rheuma), DSM Pharmacovigilance PPD Cambridge United Kingdom Dr. Farooq A. RATHORE, MBBS, FCPS Dept of Physical Medicine and Rehabilitation CMH Panno Aqil Panno Aqil Pakistan Dr. Santhanam RAVISANKAR, MPharm, PhD, MBA Clinical Development GVK Biosciences Pvt Ltd. Ameerpet India Dr. Riju RAY, MBBS, PhD Psychiatry University of Pennsylvania Philadelphia USA Dr. Denise RICHARDT, MSc, BSc Scientific and Regulatory Affairs PAREXEL International (South Africa) (Pty) Ltd. George South Africa Dr. Kamal V. S. SAINI, MBBS, MD, MRCP, DM Department of Medical Oncology Institute Jules Bordet Brussels Belgium Professor Ravi B. SAVANAL, BCom, FCA Entheos Healthcare Services Pune India Dr. Sandra L. SCHNEIDER, PhD, EMBA Research & Clinical Laboratory Systems San Antonio USA Ms, Valencia A. SHAH, BSc Clinical Trials & Epidemiological Sciences National Cancer Centre of Singapore Pte Ltd. Singapore Dr. Nikolaos SITARAS, MD, PhD Department of Pharmacology, Medical School University of Athens Athens Greece Dr. Mark A. SMITH, PhD Department of Pathology Case Western Reserve University Cleveland USA Mr. Jitendra SONI, MSc Clinical Operations Roche Scientific Company (India) Pvt. Ltd. Mumbai India Dr. Ling SU, PhD Clinical Research & Development Asia Pacific Wyeth Pharmaceutical Co., Ltd. Shanghai PR China Ms. Nicky U. SULZER, MSc, BSc, BA TREAD Clinical Trial Research Unit Tygerberg Hospital Parow South Africa Dr. Selene TAM, PhD, MMedSc, BHSc, RN Clinical Trials Centre The University of Hong Kong Hong Kong PR China Dr. Stanley W. TAM, PhD Eurofins Medinet Pte Ltd Singapore
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Dr. Alvin TAN, PhD Access to Patients Quintiles East Asia Pte. Ltd. Singapore Dr. Engel THIM, MD D2MM Ltd. London United Kingdom Dr. Edmund S. TSUEI, BSc, MSc, PhD Pharma Development Operations Roche Products Pty Limited Sydney Australia Dr. Antonio UGALDE, PhD, LLD Department of Sociology University of Texas Austin USA Ms. Esmarie A VENIER, BA, Dip Nursing Callquick Centurion South Africa Dr. Sandro VENTO, MD Department of Internal Medicine University of Botswana Gaborone Botswana Mr. Henning VOSS, MSc World Courier Hong Kong Ltd. Hong Kong PR China Mr. David VULCANO, MSW, MBA, CIP, RAC Hospital Corporation of America (HCA) Nashville USA Dr. Azeem H. WALELE, MBCHB, FCPAED Sa National Military Health Services Cape Town South Africa Dr. Vivian L. WEST, PhD, MBA Duke Clinical Research Unit Duke University Durham USA Dr. John K. WHISNANT, MD Kinexum, LLC Belle Mead USA Dr. Li XU, MD, PhD Hematology and Oncology Northwestern University Chicago USA Dr. T.J. YAO, PhD, MSc, BSc Clinical Trials Centre The University of Hong Kong Hong Kong PR China Mr. Kobra YASSINI, BSc Iranian Cochrane Informal Network Tehran Iran Mr. Henry YAU, MBA, BSc Clinical Trials Centre The University of Hong Kong Hong Kong PR China Mr. Harsha YAVAGAL, MPharm Clinical Operations PAREXEL Singapore Singapore Dr. Csiki ZOLTAN, MD, PhD, MSc Clinical Immunology Unit Debrecen University Medical Center Debrecen Hungary
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Page 34
The Taiwanese Story

For decades, Taiwan has been a popular location for industry-sponsored trials even before other emerging clinical trial countries. Taiwan also has a reputation of conducting a number of investigator-initiated clinical trials; according to the US trial registry, Taiwan has more such trials than any other country/region in Asia. Taiwan was also in the forefront to develop its own GCP guideline and established its own drug regulatory body in 1998 the Centre for Drug Regulation. This may very well be the most professional regulatory body in Asia. The person behind the establishment of the Center for Drug Regulation is the current Director, Dr. Herng-Der Chern, MD, PhD. I had the pleasure to meet up with Dr. Chern in February at an International Workshop for Clinical Trial Professionals organized by the Taipei Medical University. He informed me of a very interesting development between China and Taiwan, namely the recent signing of the Chinese version of the Cross-Strait Medical and Healthcare Cooperation Agreement on December 21, 2010. On February 25, 2011, Taiwan FDA and CDE formally announced to the public that TFDA has set up a TFDA Cross Strait Medicinal Products Affairs Office and CDE is planning for a CDE Cross Strait Medicinal Products Collaboration and Promotion Office to support the role of the TFDA in the agreement. The two parties have agreed to mutual cooperation and exchange on the following points based on the principle of equality and mutual benefit: (I) Prevention and treatment of infectious diseases, (II) Safety management and R&D of pharmaceuticals, (III) Traditional Chinese medicine (TCM) research and exchange and safety management of Chinese crude drugs, (IV) Emergency aid and treatment and (V) Other fields as agreed between the two parties. Topic II addresses Safety Management and R&D of Pharmaceuticals (a simple translation):
The pharmaceuticals referred herein include drugs, medical devices, healthcare products (health food) and cosmetics, excluding Chinese crude drugs. The two parties agree to conduct exchange and cooperation on the systems and regulations, specifications, inspection technology and other related matters of the non-clinical testing, clinical testing, pre-marketing review, production management and post-marketing management of the pharmaceuticals across the straits.
The two parties agree to set up a cooperation mechanism for the matters relating to pharmaceuticals across the straits: Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP); The notification, disposition and tracking of adverse actions and events; The auditing of fake drugs, drugs of inferior quality and drugs forbidden or drugs that violate regulations; and the exchange of information and investigation of the source of such information. The two parties agree to set up a coordination and disposition mechanism for major pharmaceutical safety events across the straits and take the following measures to deal with such events properly: Emergency consultation and exchange of related information; To take control measures in preventing the situation from spreading; To foster an environment that will allow for convenient on-site understanding of the situation; To verify and disseminate information and notify one another of such information; To analyze the cause of the event(s) and provide timely notification of the results of the investigation and disposition; To procure the responsible manufacturers and persons to deal with disputes properly and provide active assistance for the security of the manufacturers suffering damage and customers rights. The two parties agree to strengthen cooperation and actively improve the coordination of the technology standards and regulations of the two parties based on the generally acknowledged pharmaceuticals safety management standards such as ICH, GHTF, etc, so as to promote the safety and effectiveness of pharmaceuticals. The inspection and approval (examination and registration) of pharmaceuticals and the inspection and cooperation of production management regulations shall be based on the foregoing basis to probe the measures to adopt the results from the other partys implementation. The two parties agree to exchange materials and cooperate on their systems and regulations relating to clinical trials, the management of implementation authority and team, the protection of subjects rights and interests and the approval mechanism of clinical trials planning and trial results, etc. The cooperation in R & D of clinical trials and pharmaceuticals across the straits shall be
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actively strengthened in accordance with Good Clinical Practice (GCP) with the aim of reducing repetitive trials by carefully selecting pilot and special projects.
This issue of the Magnifier reports that China has finally entered the global clinical trial arena, and both China and Taiwan are showing strong recent growth in the number of industry-sponsored trial sites. With the recently established collaboration between China and Taiwan, it looks as though China is officially declaring its aims to enter the global life sciences research and development arena by meeting internal quality assurance requirements through a close collaboration with Taiwan.
Total Management Consulting Ltd. The conclusion of the workshop was that North Asia has increasingly become an important geographic area for the life sciences industry for obvious reasons, such as large patient population, large potential markets, numerous highly ranked academic institutions,
Workshop for Clinical Trial Professionals organized by the Taipei Medical University
This workshop held on February 22, 2011 addressed various aspects of clinical trials. Presentations were made by Dr. Herng-Der Chern (far right), Director, Center of Drug Evaluation, Dr. Johan Karlberg (second from right), Director, Clinical Trials Centre, The University of Hong Kong, Dr. Hung-Yi Chiou (moderator, middle), Dean, College of Public Health and Nutrition, TMU, Dr. Catherine Lee (second from left), Area Head, Clinical Operations-Emerging Market Asia, Pfizer, and Mr. Ray Wang (far left), CEO, Taiwan improving clinical research infrastructure and simplified drug regulations. For instance, South Korea has been able to develop an efficient clinical research infrastructure, and Taiwan has recently simplified the clinical trial approval process time to only two weeks for clinical trials of new medicinal products that are overseen by other recognized drug regulatory bodies. The final conclusion of the workshop was that there is a need for further clinical research infrastructure development to facilitate and accelerate clinical trial initiation and the conduct of industry-sponsored clinical trials in order to stay competitive.
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New Trial Registrations (Table 1 of 7)

The most recent industry-sponsored clinical trials testing drugs, biologicals or medical devices registered in www.ClinicalTrials.gov from January 1, 2011 and still not activated (Planning) or recruiting (Recruiting) subjects on February 28, 2011.
Status Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Link/ID NCT01284569 NCT01284582 NCT01304693 NCT01290042 NCT01300026 NCT01276262 NCT01284595 NCT01290900 NCT01291602 NCT01287598 NCT01297088 NCT01297530 NCT01300078 NCT01291732 NCT01296932 NCT01298063 NCT01303445 NCT01290575 NCT01292655 NCT01281774 NCT01288430 NCT01300858 NCT01271504 NCT01296568 NCT01299285 NCT01301092 NCT01283373 NCT01290549 NCT01296555 NCT01300247 NCT01301716 NCT01273103 NCT01283100 NCT01290354 NCT01271803 NCT01277094 NCT01292603 NCT01288989 NCT01270698 NCT01288196 NCT01281579 NCT01286103 NCT01294631 NCT01304537 NCT01293383 NCT01292993 NCT01275170 NCT01276847 NCT01293006 NCT01294735 NCT01295632 NCT01300455 NCT01304797 NCT01275209 NCT01283516 NCT01290133 NCT01277640 NCT01302925 NCT01270815 NCT01272375 NCT01272804 NCT01277991 NCT01285505 Type Biological Biological Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Phase 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Sponsor Ablynx Affiris Alcon Amgen Amgen AstraZeneca AstraZeneca AstraZeneca AstraZeneca Bayer Bayer Bayer Bionovo Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Bristol-Myers Squibb Bristol-Myers Squibb CSL Daiichi Sankyo Egen Eisai Eli Lilly Eli Lilly Eli Lilly Genentech Genentech Genentech Genentech Genentech GlaxoSmithKline GlaxoSmithKline GlaxoSmithKline Hoffmann-La Roche Hoffmann-La Roche Hoffmann-La Roche Imclone Immunomedics Janssen Johnson & Johnson Johnson & Johnson Johnson & Johnson Kamada Leo Lexicon Merck Merck Merck Merck Merck Merck Merrimack Novartis Novartis Octagen Partnership for Microbicides Peplin Pfizer Pfizer Pfizer Pfizer Pfizer Size (n) 72 36 90 56 50 56 6 45 15 40 56 58 40 48 50 38 60 64 95 72 88 30 95 12 6 32 49 99 45 40 48 6 30 10 50 80 200 40 24 32 27 32 30 24 12 18 48 40 24 54 124 24 60 50 70 Missing 48 100 28 48 60 30 26 Min Age 18 Years 18 Years 50 Years 18 Years 18 Years 18 Years 50 Years 18 Years 20 Years 18 Years 30 Years 18 Years 40 Years 20 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 30 Years 18 Years 18 Years 18 Years 35 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 10 Years 20 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 21 Years 18 Years 21 Years 18 Years Max Age 80 Years 65 Years N/A 55 Years N/A 45 Years 65 Years 45 Years 45 Years N/A 80 Years N/A 65 Years 45 Years N/A 75 Years 50 Years 70 Years N/A 55 Years N/A 80 Years N/A N/A 55 Years N/A N/A N/A N/A N/A N/A 55 Years 55 Years N/A N/A 65 Years N/A N/A N/A 55 Years 55 Years 45 Years 55 Years 25 Years 40 Years 55 Years 75 Years N/A 75 Years N/A N/A 65 Years N/A N/A N/A 65 Years N/A N/A 55 Years 55 Years 70 Years 55 Years 55 Years Condition Rheumatoid Arthritis Drug Safety Age-Related Macular Degeneration Crohn's Disease Tumors Oral Contraceptive, Rheumatoid Arthritis Healthy Healthy Healthy Japanese Neoplasms Diagnostic Imaging Neoplasms Hot Flashes Healthy Leukemia, Lymphocytic, Chronic, B-Cell Healthy Healthy Diabetes Mellitus, Type 2 Cancer Healthy Non-Small Cell Lung Carcinoma Colorectal Cancer Hepatocellular Carcinoma Advanced Cancer Healthy Diabetes Mellitus, Type II Prostate Cancer Non-Hodgkin's Lymphoma Solid Cancers Chronic Lymphocytic Leukemia Solid Cancers HIV Infections Human Immunodeficiency Virus I Infection Cancer Malignant Melanoma Liver Diseases Lymphocytic Leukemia, Chronic Neoplasms Metastatic Colorectal Cancer Healthy Healthy Healthy Healthy Type 1 Diabetes Mellitus Healthy Type 2 Diabetes Mellitus Infectious Disease Psoriasis Pulmonary Disease, Chronic Obstructive Melanoma Neoplasm, Advanced Obstructive Breast Cancer Follicular Lymphoma Tumors Postoperative Nausea and Vomiting Topical Penile Exposures Actinic Keratosis Healthy Healthy NIDDM Arthritis, Rheumatoid Healthy
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Status Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Link/ID NCT01285518 NCT01286467 NCT01291524 NCT01293487 NCT01297595 NCT01298518 NCT01299467 NCT01301456 NCT01280240 NCT01292135 NCT01295827 NCT01273246 NCT01304303 NCT01284530 NCT01299805 NCT01288755 NCT01289210 NCT01290211 NCT01273779 NCT01276223 NCT01298687 NCT01273337 NCT01291108 NCT01300013 NCT01301508 NCT01285752 NCT01288911 NCT01294020 NCT01302041 NCT01294202 NCT01283724 NCT01303783 NCT01271725 NCT01294410 NCT01273389 NCT01303744 NCT01283022 NCT01301612 NCT01279590 NCT01296243 NCT01294579 NCT01284634 NCT01280344 NCT01278134 NCT01286753 NCT01290718 NCT01282463 NCT01304524 NCT01277107 NCT01301157 NCT01283139 NCT01285401 NCT01303328 NCT01281631 NCT01272180 NCT01274351 NCT01288092 NCT01290406 NCT01297491 NCT01302886 NCT01303380 NCT01296464 NCT01304628 Type Drug Drug Drug Biological Drug Drug Drug Biological Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Phase 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 Sponsor Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer Pharmacosmos Pharmacyclics Schering-Plough Sinovac Sun Pharmaceutical Supernus Takeda Tibotec Ventirx VIIV Agennix Alcon Alcon Aldagen Allergan Amgen Anacor Asahi Kasei Kuraray Astellas Astellas Astellas Astex Bayer Bayer Boehringer Ingelheim Bristol-Myers Squibb Centocor Chiesi Cytokine Eurofarma Furiex Gentad GlaxoSmithKline GW Helsinn Hoffmann-La Roche Hoffmann-La Roche Hoffmann-La Roche Imclone Inovio Intec Maruho Medimmune Merck Serono Mithra Neuraltus Novartis Novartis Novartis Novartis Novartis Novartis Novartis Orion Palatin Size (n) 84 70 24 68 22 48 24 54 12 60 32 132 30 40 15 24 15 28 1,280 397 72 100 120 600 120 240 370 80 60 36 100 1,320 120 289 24 96 24 108 282 96 53 24 320 160 20 50 138 148 60 Missing 544 348 200 105 360 110 120 140 180 40 15 27 56 Min Age 30 Years 18 Years 18 Years 55 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 6 Months 18 Years 4 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 30 Years 18 Years 18 Years 18 Years 18 Years 18 Years 5 Years 18 Years 18 Years 12 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 40 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 21 Years 11 Years 18 Years 18 Years 18 Years 18 Years 18 Years 2 Years 30 Years 18 Years Max Age 65 Years N/A 55 Years 80 Years 55 Years 60 Years 60 Years 70 Years N/A N/A N/A 11 Years N/A 17 Years 55 Years 55 Years N/A 55 Years N/A N/A N/A 70 Years N/A N/A 65 Years 65 Years N/A 16 Years N/A N/A 17 Years N/A N/A N/A 70 Years 79 Years N/A N/A N/A N/A N/A N/A 85 Years N/A N/A 65 Years N/A 50 Years 65 Years N/A 75 Years 50 Years 50 Years 80 Years 18 Years N/A N/A N/A N/A N/A N/A N/A 65 Years Condition Diabetes Mellitus, Type 2 Solid Tumors Healthy Bone Disease Healthy Type 2 Diabetes Patients Asthma Endocrine System Diseases Chemotherapy Induced Anemia Lymphocytic Lymphoma Solid Tumors Enterovirus Solid Tumor Epilepsy Healthy HIV Infections Low Grade B-Cell Lymphoma Healthy Severe Sepsis Dry Eye Disease Glaucoma and Ocular Hypertension Nonlacunar Stroke of MCA Ocular Hypertension Heart Failure Dermatitis, Atopic Rheumatoid Arthritis Prostatic Neoplasms Intestine Transplantation Prostate Cancer Gastrointestinal Stromal Tumor Endometriosis Hypertension Breast Neoplasms Colitis, Ulcerative Systemic Lupus Erythematosus Alzheimer's Disease Labor Induced Uterine Cervix Carcinoma Hyperlipidemia Prostate Cancer Lymphoma, Non-Hodgkin Fatty Liver Gastrointestinal Dysmotility Hepatitis C, Chronic Neoplasms Breast Cancer Renal Pelvis Cervical Intraepithelial Neoplasia Insomnia Psoriasis Systemic Lupus Erythematosus Relapsing-Remitting Multiple Sclerosis Cervical Intraepithelial Neoplasia Amyotrophic Lateral Sclerosis Invasive Meningococcal Disease Chronic Myelogenous Leukemia Metastatic Breast Cancer Endometrial Cancer Non-Small Cell Lung Cancer Smoldering Myeloma Mevalonate Kinase Deficiency Parkinson's Disease Asthma
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Status Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Link/ID NCT01271933 NCT01276509 NCT01284062 NCT01287897 NCT01298492 NCT01299480 NCT01297608 NCT01294800 NCT01291173 NCT01297400 NCT01283594 NCT01275248 NCT01290692 NCT01270945 NCT01294163 NCT01297517 NCT01297920 NCT01304706 NCT01284166 NCT01294384 NCT01277510 NCT01281254 NCT01294423 NCT01294436 NCT01294462 NCT01300351 NCT01301469 NCT01286779 NCT01294215 NCT01298765 NCT01281189 NCT01289990 NCT01297270 NCT01285609 NCT01285323 NCT01287039 NCT01290887 NCT01303107 NCT01299272 NCT01295710 NCT01292473 NCT01277042 NCT01300234 NCT01295372 NCT01270997 NCT01287741 NCT01290094 NCT01288209 NCT01290731 NCT01292239 NCT01296698 NCT01293305 NCT01294683 NCT01296412 NCT01297465 NCT01289223 NCT01275196 NCT01297569 NCT01272219 NCT01272232 NCT01297309 NCT01270828 NCT01276639 Type Drug Drug Biological Drug Drug Biological Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Biological Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Phase 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 Sponsor Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer RDD Schering-Plough Shire Skingenix Synosia Transcept TVAX Xbiotech Air Liquide Alcon Alcon Alimera Allergan Allergan Amgen Amgen AstraZeneca AstraZeneca AstraZeneca AstraZeneca B Braun Baxter Bayer Biodelivery Biogen Boehringer Ingelheim Boehringer Ingelheim Bristol-Myers Squibb Cephalon Cephalon Cephalon Cristalia Eli Lilly Fresenius Genentech GlaxoSmithKline GlaxoSmithKline H Lundbeck Hanwha Hoffmann-La Roche Hoffmann-La Roche Janssen Janssen Janssen Johnson & Johnson L.A.L Clinica Merck Merck Merck Serono Mundipharma Novartis Novartis Novo Nordisk Novo Nordisk NPS Pfizer Pfizer Size (n) 290 240 80 240 200 1,716 20 440 260 14 400 150 86 80 492 750 750 40 120 297 100 380 255 700 800 220 240 60 60 300 804 1,920 625 800 400 440 740 48 2,045 250 300 1,200 494 160 300 1,400 60 90 47 183 1,500 320 1,268 600 208 125 254 30 3,600 800 40 290 825 Min Age 18 Years 18 Years 18 Years 18 Years 18 Years 11 Years 18 Years 30 Years 18 Years 18 Years 30 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years N/A 18 Years 18 Years 6 Years 18 Years 20 Years 20 Years 20 Years 18 Years 18 Years 12 Years 20 Years 18 Years 18 Years 18 Years 18 Years 18 Years 12 Years 12 Years 12 Years 18 Years 18 Years 18 Years 12 Years 26 Years 18 Years 18 Years 20 Years 18 Years 50 Years 20 Years 20 Years 20 Years 18 Years 40 Years 18 Years 18 Years 36 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years Max Age N/A 75 Years 65 Years 75 Years 75 Years 18 Years 55 Years 85 Years 55 Years 65 Years 80 Years N/A N/A N/A N/A N/A N/A N/A N/A N/A 17 Years N/A N/A N/A N/A N/A 70 Years 65 Years N/A N/A 80 Years N/A 70 Years N/A 75 Years 75 Years 75 Years 35 Years N/A 60 Years 75 Years 45 Years 69 Years 65 Years N/A N/A N/A 70 Years 70 Years 70 Years N/A N/A 85 Years 79 Years 40 Years N/A N/A N/A N/A N/A 85 Years N/A N/A Condition Fibromyalgia Crohn's Disease Colitis, Ulcerative Crohn's Disease Crohn's Disease Meningococcal Vaccine Fecal Incontinenece Parkinson's Disease Binge Eating Disorder Partial Thickness Burn Parkinson's Disease Obsessive-Compulsive Disorder Glioblastoma Multiforme Repeat Peripheral Artery Revascularization Coronary Artery Bypass Ocular Hypertension Ocular Hypertension Diabetic Macular Edema Ocular Hypertension Dry Eye Syndromes Secondary Hyperparathyroidism Primary Peritoneal Cancer High Blood Sugar High Blood Sugar Percutaneous Coronary Intervention Breast Cancer Blood Pressure Disorders and Shock Hemophilia B Hypertension Neuralgia Amyotrophic Lateral Sclerosis Diabetes Mellitus, Type 2 Hepatitis C Lung Cancer - Non Small Cell Eosinophilic Asthma Eosinophilic Asthma Eosinophilic Asthma Cesarean Delivery Major Depressive Disorder Chronic Graft Versus Host Disease Chronic Idiopathic Urticaria Cervical Neoplasia Chronic Hepatitis B Schizophrenia Rheumatoid Arthritis Lymphoma, B-Cell Post-Menopausal Osteoporosis Hepatitis C, Chronic Hepatitis C, Chronic Hepatitis C, Chronic Tobacco Dependence Osteoarthritis Dyslipidemia Diabetes Mellitus, Type 2 Reproductive Technology, Assisted Indolent B-Cell Nhl Chronic Myeloid Leukemia Diabetic Macular Edema Obesity Obesity Hypoparathyroidism Post Herpetic Neuralgia Psoriasis
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Status Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Planning Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Link/ID NCT01293201 NCT01292460 NCT01303406 NCT01277211 NCT01274221 NCT01296620 NCT01272089 NCT01298700 NCT01295294 NCT01289847 NCT01298843 NCT01277302 NCT01288027 NCT01277601 NCT01271010 NCT01283386 NCT01283971 NCT01287754 NCT01277822 NCT01276431 NCT01279850 NCT01298466 NCT01298531 NCT01302054 NCT01302067 NCT01302080 NCT01302938 NCT01288625 NCT01275625 NCT01292941 NCT01299324 NCT01295619 NCT01303718 NCT01292928 NCT01285960 NCT01299155 NCT01279031 NCT01283425 NCT01277406 NCT01287858 NCT01290029 NCT01294397 NCT01297062 NCT01279538 NCT01284192 NCT01284920 NCT01283984 NCT01287845 NCT01281111 NCT01286987 NCT01276288 NCT01276301 NCT01276327 NCT01282970 NCT01284621 NCT01286571 NCT01290757 NCT01301742 NCT01304329 NCT01290471 NCT01294540 NCT01275144 NCT01275157 Type Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Device Device Device Device Device Device Device Device Device Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Phase 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 1 1 1 3 3 3 4 4 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Sponsor Pharmaceuticals Santen Santhera Schering-Plough Shire Tranzyme Alcon Allergan Bayer Bio Cerexa Genentech Genzyme Gilead Hoffmann-La Roche Hoffmann-La Roche Hoffmann-La Roche Hoffmann-La Roche Merck Mundipharma Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer Sun Pharmaceutical VIIV Coloplast Harvest Kuros Biocontrol Boston Scientific Insightec Alcon Innovative Medical Insuline 4SC Ambit Amgen Amgen Amylin Astellas Astellas Astellas AstraZeneca Bayer Biogen Biomarin Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Daiichi Sankyo Eisai Eli Lilly Eli Lilly Size (n) 300 600 80 720 158 315 200 784 186 25 56 190 15 720 200 200 700 20 296 102 300 600 80 3,143 1,990 900 600 150 110 55 60 40 650 300 106 20 25 120 80 88 12 44 100 45 50 46 96 25 56 70 20 16 64 72 24 14 180 18 18 66 48 28 6 Min Age 12 Years 18 Years 8 Years 18 Years 13 Years 18 Years 18 Years 18 Years 18 Years 2 Years N/A 18 Years 18 Years 18 Years 18 Years 60 Years 18 Years 18 Years 18 Years 50 Years N/A 18 Years 18 Years 18 Years 18 Years 6 Years 21 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 21 Years 21 Years 18 Years 18 Years 18 Years N/A 45 Years 18 Years 18 Years 18 Years 20 Years 18 Years 18 Years 18 Years 18 Years 20 Years 18 Years 18 Years 20 Years 18 Years 18 Years 21 Years 18 Years 18 Years 18 Years 30 Years 18 Years 18 Years Max Age 60 Years N/A N/A 40 Years 17 Years 80 Years N/A N/A 45 Years 16 Years 11 Years N/A 65 Years 75 Years 70 Years N/A N/A N/A 80 Years 75 Years N/A N/A N/A N/A N/A 14 Years N/A 70 Years N/A N/A N/A N/A N/A N/A N/A N/A N/A 65 Years N/A 45 Years 2190 Days 80 Years 65 Years 65 Years N/A N/A 45 Years N/A 55 Years N/A 65 Years 50 Years 55 Years 70 Years 55 Years 55 Years 55 Years 55 Years 50 Years N/A 85 Years 65 Years 55 Years Condition Seasonal Allergic Rhinitis Open-Angle Glaucoma Friedreich's Ataxia Contraception Attention Deficit Hyperactivity Disorder Gastrointestinal Dysmotility Allergic Conjunctivitis Ocular Hypertension Uterine Hemorrhage Wiskott-Aldrich Syndrome Infections Macular Edema Glycogenesis 2 Acid Maltase Deficiency Chronic Hepatitis B Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Chronic Rheumatoid Arthritis Non-Small Cell Lung Cancer Hypertension Osteoarthritis Pain of The Hip/Knee Neuralgia Neuralgia Axial Spondyloarthritis Overactive Urinary Bladder Overactive Bladder Obsessive Compulsive Disorder Overactive Bladder Stomatitis HIV Infections Spinal Cord Injury Congestive Heart Failure Cerebralspinal Fluid Leakage Heart Failure Atherosclerosis of Extremities Uterine Fibroid(S) Cataract Astigmatism Diabetes Mellitus, Type 1 Advanced Colorectal Carcinoma Rheumatoid Arthritis Secondary Hyperparathyroidism Rheumatoid Arthritis Healthy Subjects Kidney Transplantation Solid Tumors Castration Resistant Prostate Cancer Persistent Narrowing of Airways Diagnostic Imaging Healthy Advanced/Recurrent Solid Tumors Diabetes Mellitus, Type 2 Healthy Healthy Diabetes Mellitus, Type 2 Healthy Healthy Healthy Healthy Healthy Advanced Ovarian Cancer Alzheimer's Disease Major Depressive Disorder Healthy
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Status Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Link/ID NCT01284335 NCT01285037 NCT01287520 NCT01287546 NCT01300260 NCT01283945 NCT01278095 NCT01278108 NCT01287091 NCT01288573 NCT01299298 NCT01277692 NCT01294566 NCT01275131 NCT01286818 NCT01296386 NCT01273467 NCT01273506 NCT01273532 NCT01279291 NCT01297166 NCT01281592 NCT01290302 NCT01302990 NCT01284231 NCT01297205 NCT01297218 NCT01304784 NCT01278758 NCT01278849 NCT01283503 NCT01285466 NCT01290419 NCT01272973 NCT01288391 NCT01296438 NCT01296451 NCT01274624 NCT01277146 NCT01297582 NCT01289080 NCT01299454 NCT01301443 NCT01273948 NCT01274663 NCT01287793 NCT01299636 NCT01282684 NCT01271972 NCT01289756 NCT01293630 NCT01279083 NCT01299727 NCT01273233 NCT01280786 NCT01292174 NCT01291004 NCT01288677 NCT01288742 NCT01300611 NCT01271387 NCT01275599 NCT01271348 Type Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Biological Drug Drug Drug Biological Drug Drug Drug Biological Drug Biological Biological Drug Drug Drug Drug Drug Biological Drug Drug Drug Biological Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Biological Biological Drug Biological Drug Drug Drug Drug Drug Drug Drug Phase 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Sponsor Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly EOS Galapagos Galapagos Genentech Genzyme Genzyme GlaxoSmithKline GlaxoSmithKline Halozyme Imclone Intercell Johnson & Johnson Johnson & Johnson Johnson & Johnson Kyowa Leo Lotus Luitpold Medicago Medimmune Medipost Medipost Merrimack Novartis Novartis Novartis Novartis Novavax Novo Nordisk Novo Nordisk Novo Nordisk Okairos Oncolytics Oncomed Ono Otsuka Otsuka Oxford Biomedica Peregrine Pfizer Pfizer Pharmamar Plexxikon Regeneron Robert Bosch Sanofi-Aventis Santen Shire Sinovac Synta Taimed Teva Tibotec Tibotec US Biotest Vanda Vertex X-Pert Size (n) 230 114 50 81 35 60 12 40 50 67 20 70 16 36 9 160 Missing 30 30 78 25 30 56 100 112 9 9 24 24 39 30 42 100 96 15 40 23 12 44 56 20 44 18 66 63 48 35 48 34 15 30 144 12 36 36 24 160 54 Missing 10 32 16 50 Min Age 18 Years 18 Years 25 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 2 Years 20 Years 18 Years 18 Years 18 Years 20 Years 18 Years 18 Years 20 Years 20 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years N/A 50 Years 18 Years 18 Years 18 Years 20 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 50 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 20 Years 18 Years 3 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years Max Age N/A N/A N/A N/A 65 Years N/A 50 Years 50 Years 65 Years 18 Years 45 Years 65 Years 65 Years 65 Years N/A N/A 80 Years 45 Years 45 Years N/A N/A N/A N/A 49 Years N/A 14 Days 75 Years N/A N/A N/A N/A N/A 49 Years 60 Years N/A 65 Years 65 Years N/A 90 Years 55 Years N/A N/A N/A 65 Years 45 Years 55 Years N/A 65 Years N/A 45 Years 75 Years N/A N/A 49 Years N/A 40 Years 35 Years 55 Years 55 Years 60 Years 75 Years 64 Years 70 Years Condition Advanced Solid Tumors Cancer Advanced Cancer Advanced Cancer Diabetes Mellitus, Type 2 Solid Tumors Healthy Healthy Healthy Brain Tumors Healthy Hepatitis C Gastroparesis Type 1 Diabetes Mellitus Colorectal Carcinoma Clostridium Difficile Infection Infarction Healthy Healthy Primary Peritoneal Neoplasm Psoriasis Vulgaris Advanced or Metastatic Solid Tumours Dysmyelopoietic Syndromes Influenza Gastrointestinal Adenocarcinomas Bronchopulmonary Dysplasia Alzheimer's Disease C-Erbb2 Gene Amplification Metastatic Cancer Solid Tumors Advanced Solid Tumor Solid Tumors Respiratory Syncytial Virus Infections Diabetes Mellitus, Type 2 Haemophilia B Diabetes Mellitus, Type 1 Hepatitis C Colorectal Cancer Solid Tumors Healthy Adult Subjects Mental Disorders Schizophrenia Age Related Macular Degeneration Hepatitis C Diabetes Mellitus, Type 2 Healthy Solid Tumour Healthy Solid Tumour Cytochrome P450 Cyp3a Enzyme Deficiency Advanced Solid Tumors Ocular Hypertension MPS III Infection; Viral, Enterovirus Acute Myeloid Leukemia Prevention of Infection with HIV-1 Oral Contraceptive Healthy Hepatitis C Virus Chronic Lymphocytic Leukemia Hepatic Impairment Opioid-Related Disorders Muscle Pain
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Status Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Link/ID NCT01301677 NCT01303978 NCT01275755 NCT01302249 NCT01283698 NCT01300052 NCT01281423 NCT01289574 NCT01274000 NCT01288079 NCT01297244 NCT01289431 NCT01289821 NCT01301781 NCT01282424 NCT01281202 NCT01281462 NCT01291901 NCT01279577 NCT01271790 NCT01286740 NCT01287065 NCT01299610 NCT01277341 NCT01284387 NCT01303224 NCT01280695 NCT01301391 NCT01281306 NCT01289041 NCT01294774 NCT01302873 NCT01302899 NCT01282255 NCT01272791 NCT01272258 NCT01270841 NCT01273376 NCT01283581 NCT01286012 NCT01276548 NCT01288443 NCT01288469 NCT01282606 NCT01282619 NCT01304277 NCT01293669 NCT01296087 NCT01292187 NCT01285583 NCT01302600 NCT01285700 NCT01270971 NCT01302119 NCT01303679 NCT01298752 NCT01280591 NCT01287260 NCT01275066 NCT01277523 NCT01286558 NCT01303796 Type Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Phase 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 Sponsor X-Pert Acacia Pharma Ltd Adolor Aerie Almirall Anacor Anadys Androscience Astellas AstraZeneca Aveo Bausch & Lomb Bayer Braintree Calistoga Catalyst Cerexa Diamyd Dr. Falk Gilead Gilead GlaxoSmithKline GlaxoSmithKline Ista Janssen Menarini Metabolic Solutions Nerviano Novartis Novartis Novartis Novartis Novartis Novo Nordisk Peregrine Progenics Repros Rexahn Rib-X Rockwell Samyang Sanofi-Aventis Sanofi-Aventis Seikagaku Shandong Luye Shire Targacept Targacept Tarsa Trophos Trophos Zymenex Anacor Anacor Arcagy Bausch & Lomb Bayer Bayer Biomarin Boehringer Ingelheim Boehringer Ingelheim Cyclacel Size (n) 47 40 80 60 20 60 274 180 360 352 100 210 41 45 120 200 215 32 212 320 50 24 25 600 108 560 125 35 910 140 24 92 32 66 70 75 120 300 240 100 Missing 180 90 18 390 30 120 120 120 350 150 10 600 600 198 300 800 434 162 192 200 470 Min Age 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 12 Years 20 Years 18 Years 18 Years 12 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 12 Years 50 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 21 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years 30 Years 50 Years 18 Years 18 Years 18 Years 45 Years N/A 3 Years 5 Years 18 Years 18 Years 18 Years 18 Years 12 Years 20 Years 5 Years 12 Years 20 Years 70 Years Max Age N/A N/A 75 Years N/A 75 Years N/A 65 Years N/A 64 Years 65 Years N/A N/A N/A N/A N/A N/A N/A N/A 75 Years 70 Years N/A 70 Years 65 Years N/A 89 Years 70 Years 75 Years N/A N/A N/A 65 Years 75 Years 70 Years 75 Years N/A N/A 65 Years 65 Years N/A N/A N/A 75 Years 75 Years 70 Years 85 Years 65 Years 65 Years 65 Years N/A N/A 25 Years 21 Years N/A N/A N/A N/A 45 Years N/A N/A 17 Years N/A N/A Condition Pain Chemotherapy-Induced Nausea/Vomiting Constipation Ocular Hypertension Psoriasis Vulgaris Psoriasis Hepatitis C Acne Irritable Bowel Syndrome Major Depressive Disorder Renal Cell Carcinoma Conjunctivitis, Allergic Colorectal Neoplasms Constipation Marginal Zone B-Cell Lymphoma Cocaine Dependence Urinary Tract Infections Neoplasms Crohns Disease Hepatitis C, Chronic HIV-1 Infection Asthma Dermatitis, Atopic Seasonal Allergic Rhinitis Alzheimer's Disease Irritable Bowel Syndrome With Diarrhea Diabetes Mellitus, Type 2 Thymic Carcinoma Systolic Hypertension Advanced Endometrial Cancer Subacute Cutaneous Lupus Erythematosus Chronic Subjective Tinnitus Patients with Non-Diabetic Nephropathy Inflammation Metastatic Pancreatic Cancer HIV Infections Preservation of Reproductive Status Major Depressive Disorder Acute Bacterial Skin Infections End Stage Renal Disease Ovarian Cancer Hypercholesterolemia Hypercholesterolemia Lumbar Vertebra Hernia Alzheimer's Disease Fabry Disease Type 2 Diabetes Mellitus Asthma Osteoporosis, Postmenopausal Amyotrophic Lateral Sclerosis Spinal Muscular Atrophy Type III Alpha Mannosidosis Onychomycosis of Toenails Onychomycosis of Toenails First Line Metastatic Breast Cancer Cataract Pain, Postoperative Hypertension MPS IV A Asthma Hypertension Acute Myeloid Leukemia
Page 42

Status Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Link/ID NCT01295060 NCT01280188 NCT01287117 NCT01277666 NCT01271868 NCT01281527 NCT01299389 NCT01294644 NCT01299376 NCT01302691 NCT01289015 NCT01290341 NCT01301833 NCT01270347 NCT01304810 NCT01272934 NCT01272947 NCT01274897 NCT01285492 NCT01289028 NCT01291511 NCT01294787 NCT01302860 NCT01272193 NCT01302392 NCT01280331 NCT01287949 NCT01304498 NCT01293643 NCT01298219 NCT01285557 NCT01281839 NCT01289782 NCT01290679 Type Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Drug Biological Drug Drug Biological Drug Drug Drug Drug Biological Drug Drug Drug Biological Biological Drug Drug Drug Drug Drug Drug Phase 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 Sponsor Endo Ferring Genentech GlaxoSmithKline Inspiration Janssen Janssen Kythera Merck Merck Merz Merz Mitsubishi MPEX Nabi Novartis Novartis Novartis Novartis Novartis Novartis Novartis Novartis Novo Nordisk Onyx Qrxpharma Sanofi Pasteur Msd Sanofi Pasteur Msd Schering-Plough Sucampo Taiho Tibotec Tibotec Tibotec Size (n) 18 20 300 600 22 1,000 308 360 272 326 849 849 380 267 300 200 200 450 160 206 710 80 15 268 84 375 335 600 100 420 500 375 375 375 Min Age 18 Years 6 Years 12 Years 18 Years N/A 18 Years 20 Years 18 Years 20 Years 20 Years 12 Years 12 Years 20 Years 12 Years 18 Years 18 Years 18 Years 11 Years 40 Years 18 Years 18 Years 40 Years N/A 20 Years 18 Years 18 Years 40 Years 9 Years 18 Years 18 Years 18 Years 18 Years 18 Years 18 Years Max Age N/A 75 Years 75 Years N/A 12 Years N/A N/A 65 Years 80 Years 80 Years N/A N/A N/A N/A 65 Years N/A N/A 55 Years N/A N/A 65 Years N/A 4 Years N/A N/A N/A N/A 15 Years 45 Years N/A N/A N/A N/A N/A Condition Acromegaly Central Diabetes Insipidus Chronic Idiopathic Urticaria Crohn's Disease Hemophilia B Schizophrenia Schizophrenia Healthy Hypertension Hypertension Tinea Pedis Tinea Pedis Type 2 Diabetes Mellitus Cystic Fibrosis Nicotine Dependence Acute Ankle Sprain Acute Blunt Soft Tissue Injuries/Contusions Meningococcal Meningitis Chronic Obstructive Pulmonary Disease Gastrointestinal Stromal Tumors Schizophrenia COPD Neonatal Onset Multisystem Inflammatory Disease Diabetes Mellitus, Type 2 Multiple Myeloma Postoperative Pain Pertussis Human Papillomavirus Candidiasis, Vulvovaginal Opioid-Induced Bowel Dysfunction Gastric Cancer Hepatitis C Hepatitis C Hepatitis C
Page 43
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The Establishment of Emerging Trial Regions

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The Establishment of Emerging Trial Regions

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C L I N I C A L T R I A L M AGNIFIER

Feb 2011 Volume 4, Issue 1

The Establishment of Emerging Regions

Contents of this Issue

25-32 34-35 36-42

Magnifier Advisory Board Members.

Clinical Trial Conferences

Clinical Trial Magnifier 2011 Conference,

Clinical Trial Reporting Trends

Clinical Trial Magnifier Vol. 4:1 Feb 2011

Something about nothing

Stockholm 59 North and -11 C

Clinical Trial Magnifier

Clinical Trial Magnifier Vol. 4:1 Feb 2011

Something about a new thing

Hong Kong 22 North and +11 C

Emerging early phase trials

Copy and paste

Dunedin 46 South and +21 C

Clinical Trial Magnifier Vol. 4:1 Feb 2011

Clinical Trial Magnifier Vol. 4:1 Feb 2011

Clinical Trial Magnifier

Clinical Research Infrastructure Development

Clinical Trial Magnifier Vol. 4:1 Feb 2011

Clinical Trial Magnifier Vol. 4:1 Feb 2011